Trial Outcomes & Findings for A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years (NCT NCT02561195)

NCT ID: NCT02561195

Last Updated: 2021-03-08

Results Overview

Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

300 participants

Primary outcome timeframe

Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)

Results posted on

2021-03-08

Participant Flow

Participants initially randomized in the month and day regimens who received the first 3 doses of Clostridium difficile vaccine (100 micro gram (mcg) or 200 mcg) were enrolled into the extension stage.

Participant milestones

Participant milestones
Measure	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen Participants received 100 microgram (mcg) of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Placebo: Day 1, 8 and 30 Regimen Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg): Month 0, 1 and 6 Regimen Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.	Clostridium Difficile Vaccine(200 mcg): Month 0, 1 and 6 Regimen Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.	Placebo: Month 0, 1 and 6 Regimen Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received a fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Vaccination 1 to 3 STARTED	183	184	61	183	183	61	0	0	0	0	0	0	0	0
Vaccination 1 to 3 Treated	182	184	61	183	183	61	0	0	0	0	0	0	0	0
Vaccination 1 to 3 COMPLETED	160	162	55	157	155	51	0	0	0	0	0	0	0	0
Vaccination 1 to 3 NOT COMPLETED	23	22	6	26	28	10	0	0	0	0	0	0	0	0
Extension Stage (Vaccination 4) STARTED	0	0	0	0	0	0	16	18	24	22	51	52	58	59
Extension Stage (Vaccination 4) COMPLETED	0	0	0	0	0	0	14	17	21	20	43	45	51	54
Extension Stage (Vaccination 4) NOT COMPLETED	0	0	0	0	0	0	2	1	3	2	8	7	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen Participants received 100 microgram (mcg) of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Placebo: Day 1, 8 and 30 Regimen Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg): Month 0, 1 and 6 Regimen Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.	Clostridium Difficile Vaccine(200 mcg): Month 0, 1 and 6 Regimen Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.	Placebo: Month 0, 1 and 6 Regimen Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received a fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Vaccination 1 to 3 Adverse Event	4	5	0	3	4	0	0	0	0	0	0	0	0	0
Vaccination 1 to 3 Lost to Follow-up	3	4	0	2	3	3	0	0	0	0	0	0	0	0
Vaccination 1 to 3 No longer meets eligibility criteria	0	1	0	4	4	1	0	0	0	0	0	0	0	0
Vaccination 1 to 3 No longer willing to participate	2	4	0	4	1	3	0	0	0	0	0	0	0	0
Vaccination 1 to 3 Other	7	3	1	7	5	1	0	0	0	0	0	0	0	0
Vaccination 1 to 3 Protocol Violation	1	0	1	2	5	2	0	0	0	0	0	0	0	0
Vaccination 1 to 3 Death	2	1	0	2	0	0	0	0	0	0	0	0	0	0
Vaccination 1 to 3 Withdrawal by Subject	3	4	4	2	6	0	0	0	0	0	0	0	0	0
Vaccination 1 to 3 Randomized but not treated	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Extension Stage (Vaccination 4) Withdrew consent	0	0	0	0	0	0	0	0	3	1	2	2	3	0
Extension Stage (Vaccination 4) Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	0	2
Extension Stage (Vaccination 4) Death	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Extension Stage (Vaccination 4) Lost to Follow-up	0	0	0	0	0	0	1	1	0	0	2	1	2	1
Extension Stage (Vaccination 4) No Longer Willing To Participate In Study	0	0	0	0	0	0	0	0	0	0	0	1	1	1
Extension Stage (Vaccination 4) Other	0	0	0	0	0	0	0	0	0	0	2	2	1	0
Extension Stage (Vaccination 4) Protocol Violation	0	0	0	0	0	0	1	0	0	0	2	1	0	1

Baseline Characteristics

A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=182 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=184 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Placebo: Day 1, 8 and 30 Regimen n=61 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen n=183 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.	Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen n=183 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.	Placebo: Month 0, 1 and 6 Regimen n=61 Participants Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.	Total n=854 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical >=65 years	182 Participants n=5 Participants	184 Participants n=7 Participants	61 Participants n=5 Participants	183 Participants n=4 Participants	183 Participants n=21 Participants	61 Participants n=8 Participants	854 Participants n=8 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	106 Participants n=7 Participants	35 Participants n=5 Participants	93 Participants n=4 Participants	97 Participants n=21 Participants	37 Participants n=8 Participants	461 Participants n=8 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	78 Participants n=7 Participants	26 Participants n=5 Participants	90 Participants n=4 Participants	86 Participants n=21 Participants	24 Participants n=8 Participants	393 Participants n=8 Participants
Race/Ethnicity, Customized Race: White	172 Participants n=5 Participants	168 Participants n=7 Participants	59 Participants n=5 Participants	151 Participants n=4 Participants	157 Participants n=21 Participants	56 Participants n=8 Participants	763 Participants n=8 Participants
Race/Ethnicity, Customized Race: Black	6 Participants n=5 Participants	16 Participants n=7 Participants	2 Participants n=5 Participants	16 Participants n=4 Participants	13 Participants n=21 Participants	3 Participants n=8 Participants	56 Participants n=8 Participants
Race/Ethnicity, Customized Race: Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	13 Participants n=4 Participants	10 Participants n=21 Participants	1 Participants n=8 Participants	26 Participants n=8 Participants
Race/Ethnicity, Customized Race: Other	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	9 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity: Non-Hispanic	127 Participants n=5 Participants	143 Participants n=7 Participants	48 Participants n=5 Participants	168 Participants n=4 Participants	172 Participants n=21 Participants	57 Participants n=8 Participants	715 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity: Hispanic	55 Participants n=5 Participants	41 Participants n=7 Participants	13 Participants n=5 Participants	15 Participants n=4 Participants	11 Participants n=21 Participants	4 Participants n=8 Participants	139 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.

Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=165 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37	12.5 percentage of participants Interval 5.2 to 24.1	68.4 percentage of participants Interval 60.9 to 75.3	85.5 percentage of participants Interval 79.1 to 90.5	—

PRIMARY outcome

Timeframe: Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Month 7	1.9 percentage of participants Interval 0.0 to 10.1	98.2 percentage of participants Interval 94.7 to 99.6	95.6 percentage of participants Interval 91.1 to 98.2	—

PRIMARY outcome

Timeframe: Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)

Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=165 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 37	1.8 percentage of participants Interval 0.0 to 9.6	29.8 percentage of participants Interval 23.1 to 37.3	38.8 percentage of participants Interval 31.3 to 46.7	—

PRIMARY outcome

Timeframe: Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Month 7	7.5 percentage of participants Interval 2.1 to 18.2	74.8 percentage of participants Interval 67.5 to 81.3	87.3 percentage of participants Interval 81.1 to 92.1	—

PRIMARY outcome

Timeframe: Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)

Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=165 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 37	0.0 percentage of participants Interval 0.0 to 6.4	26.3 percentage of participants Interval 19.9 to 33.6	38.8 percentage of participants Interval 31.3 to 46.7	—

PRIMARY outcome

Timeframe: Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Month 7	0.0 percentage of participants Interval 0.0 to 6.7	74.2 percentage of participants Interval 66.8 to 80.8	86.1 percentage of participants Interval 79.7 to 91.1	—

PRIMARY outcome

Timeframe: within 7 days After Vaccination 1

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (grade 1) (did not interfere with activity), moderate (grade 2)(interfered with activity), severe (grade 3) (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 centimeter \[cm\]), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis).

Outcome measures

PRIMARY outcome

Timeframe: within 14 days After Vaccination 1

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N" signifies number of participants evaluable for this outcome measure.

Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis).

Outcome measures

PRIMARY outcome

Timeframe: within 14 days After Vaccination 2

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N" signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=58 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=180 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=179 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Pain: Any	0.0 percentage of participants Interval 0.0 to 6.2	31.7 percentage of participants Interval 24.9 to 39.0	41.3 percentage of participants Interval 34.0 to 48.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Pain: Mild	0.0 percentage of participants Interval 0.0 to 6.2	25.6 percentage of participants Interval 19.4 to 32.6	36.3 percentage of participants Interval 29.3 to 43.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Pain: Moderate	0.0 percentage of participants Interval 0.0 to 6.2	6.1 percentage of participants Interval 3.1 to 10.7	4.5 percentage of participants Interval 1.9 to 8.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Pain: Severe	0.0 percentage of participants Interval 0.0 to 6.2	0.0 percentage of participants Interval 0.0 to 2.0	0.6 percentage of participants Interval 0.0 to 3.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Pain: Grade 4	0.0 percentage of participants Interval 0.0 to 6.2	0.0 percentage of participants Interval 0.0 to 2.0	0.0 percentage of participants Interval 0.0 to 2.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Redness: Any	1.7 percentage of participants Interval 0.0 to 9.2	4.4 percentage of participants Interval 1.9 to 8.6	6.7 percentage of participants Interval 3.5 to 11.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Redness: Mild	1.7 percentage of participants Interval 0.0 to 9.2	1.1 percentage of participants Interval 0.1 to 4.0	2.8 percentage of participants Interval 0.9 to 6.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Redness: Moderate	0.0 percentage of participants Interval 0.0 to 6.2	1.7 percentage of participants Interval 0.3 to 4.8	1.7 percentage of participants Interval 0.3 to 4.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Redness: Severe	0.0 percentage of participants Interval 0.0 to 6.2	1.7 percentage of participants Interval 0.3 to 4.8	2.2 percentage of participants Interval 0.6 to 5.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Redness: Grade 4	0.0 percentage of participants Interval 0.0 to 6.2	0.0 percentage of participants Interval 0.0 to 2.0	0.0 percentage of participants Interval 0.0 to 2.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Swelling: Any	0.0 percentage of participants Interval 0.0 to 6.2	3.3 percentage of participants Interval 1.2 to 7.1	5.6 percentage of participants Interval 2.7 to 10.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Swelling: Mild	0.0 percentage of participants Interval 0.0 to 6.2	1.1 percentage of participants Interval 0.1 to 4.0	3.9 percentage of participants Interval 1.6 to 7.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Swelling: Moderate	0.0 percentage of participants Interval 0.0 to 6.2	0.6 percentage of participants Interval 0.0 to 3.1	1.1 percentage of participants Interval 0.1 to 4.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Swelling: Severe	0.0 percentage of participants Interval 0.0 to 6.2	1.7 percentage of participants Interval 0.3 to 4.8	0.6 percentage of participants Interval 0.0 to 3.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 Swelling: Grade 4	0.0 percentage of participants Interval 0.0 to 6.2	0.0 percentage of participants Interval 0.0 to 2.0	0.0 percentage of participants Interval 0.0 to 2.0	—

PRIMARY outcome

Timeframe: within 14 days after Vaccination 2

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N" signifies number of participants evaluable for this outcome measure.

Outcome measures

PRIMARY outcome

Timeframe: within 14 days after Vaccination 3

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N" signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=57 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=175 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Redness: Grade 4	0.0 percentage of participants Interval 0.0 to 6.3	0.0 percentage of participants Interval 0.0 to 2.1	0.0 percentage of participants Interval 0.0 to 2.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Pain: Any	3.5 percentage of participants Interval 0.4 to 12.1	22.9 percentage of participants Interval 16.9 to 29.8	22.2 percentage of participants Interval 16.2 to 29.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Pain: Mild	3.5 percentage of participants Interval 0.4 to 12.1	18.9 percentage of participants Interval 13.4 to 25.5	21.1 percentage of participants Interval 15.2 to 27.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Pain: Moderate	0.0 percentage of participants Interval 0.0 to 6.3	4.0 percentage of participants Interval 1.6 to 8.1	1.2 percentage of participants Interval 0.1 to 4.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Pain: Severe	0.0 percentage of participants Interval 0.0 to 6.3	0.0 percentage of participants Interval 0.0 to 2.1	0.0 percentage of participants Interval 0.0 to 2.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Pain: Grade 4	0.0 percentage of participants Interval 0.0 to 6.3	0.0 percentage of participants Interval 0.0 to 2.1	0.0 percentage of participants Interval 0.0 to 2.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Redness: Any	0.0 percentage of participants Interval 0.0 to 6.3	2.3 percentage of participants Interval 0.6 to 5.7	5.3 percentage of participants Interval 2.4 to 9.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Redness: Mild	0.0 percentage of participants Interval 0.0 to 6.3	1.1 percentage of participants Interval 0.1 to 4.1	1.8 percentage of participants Interval 0.4 to 5.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Redness: Moderate	0.0 percentage of participants Interval 0.0 to 6.3	1.1 percentage of participants Interval 0.1 to 4.1	3.5 percentage of participants Interval 1.3 to 7.5	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Redness: Severe	0.0 percentage of participants Interval 0.0 to 6.3	0.0 percentage of participants Interval 0.0 to 2.1	0.0 percentage of participants Interval 0.0 to 2.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Swelling: Any	0.0 percentage of participants Interval 0.0 to 6.3	2.9 percentage of participants Interval 0.9 to 6.5	5.3 percentage of participants Interval 2.4 to 9.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Swelling: Mild	0.0 percentage of participants Interval 0.0 to 6.3	2.3 percentage of participants Interval 0.6 to 5.7	2.9 percentage of participants Interval 1.0 to 6.7	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Swelling: Moderate	0.0 percentage of participants Interval 0.0 to 6.3	0.6 percentage of participants Interval 0.0 to 3.1	2.3 percentage of participants Interval 0.6 to 5.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Swelling: Severe	0.0 percentage of participants Interval 0.0 to 6.3	0.0 percentage of participants Interval 0.0 to 2.1	0.0 percentage of participants Interval 0.0 to 2.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Swelling: Grade 4	0.0 percentage of participants Interval 0.0 to 6.3	0.0 percentage of participants Interval 0.0 to 2.1	0.0 percentage of participants Interval 0.0 to 2.1	—

PRIMARY outcome

Timeframe: within 14 days after Vaccination 3

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N" signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=54 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=168 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=161 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Pain: Any	1.9 percentage of participants Interval 0.0 to 9.9	22.0 percentage of participants Interval 16.0 to 29.1	26.1 percentage of participants Interval 19.5 to 33.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Pain: Mild	0.0 percentage of participants Interval 0.0 to 6.6	19.6 percentage of participants Interval 13.9 to 26.5	21.7 percentage of participants Interval 15.6 to 28.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Pain: Moderate	1.9 percentage of participants Interval 0.0 to 9.9	1.8 percentage of participants Interval 0.4 to 5.1	4.3 percentage of participants Interval 1.8 to 8.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Pain: Severe	0.0 percentage of participants Interval 0.0 to 6.6	0.6 percentage of participants Interval 0.0 to 3.3	0.0 percentage of participants Interval 0.0 to 2.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Pain: Grade 4	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 2.2	0.0 percentage of participants Interval 0.0 to 2.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Redness: Any	0.0 percentage of participants Interval 0.0 to 6.6	4.2 percentage of participants Interval 1.7 to 8.4	4.3 percentage of participants Interval 1.8 to 8.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Redness: Mild	0.0 percentage of participants Interval 0.0 to 6.6	3.6 percentage of participants Interval 1.3 to 7.6	3.7 percentage of participants Interval 1.4 to 7.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Redness: Moderate	0.0 percentage of participants Interval 0.0 to 6.6	0.6 percentage of participants Interval 0.0 to 3.3	0.6 percentage of participants Interval 0.0 to 3.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Redness: Severe	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 2.2	0.0 percentage of participants Interval 0.0 to 2.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Redness: Grade 4	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 2.2	0.0 percentage of participants Interval 0.0 to 2.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Swelling: Any	0.0 percentage of participants Interval 0.0 to 6.6	2.4 percentage of participants Interval 0.7 to 6.0	5.0 percentage of participants Interval 2.2 to 9.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Swelling: Mild	0.0 percentage of participants Interval 0.0 to 6.6	2.4 percentage of participants Interval 0.7 to 6.0	4.3 percentage of participants Interval 1.8 to 8.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Swelling: Moderate	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 2.2	0.6 percentage of participants Interval 0.0 to 3.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Swelling: Severe	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 2.2	0.0 percentage of participants Interval 0.0 to 2.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 Swelling: Grade 4	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 2.2	0.0 percentage of participants Interval 0.0 to 2.3	—

PRIMARY outcome

Timeframe: within 7 days after Vaccination 1

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N" signifies number of participants evaluable for this outcome measure.

Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 degree Celsius (C)), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).

Outcome measures

PRIMARY outcome

Timeframe: within 14 days after Vaccination 1

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N" signifies number of participants evaluable for this outcome measure.

Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).

Outcome measures

PRIMARY outcome

Timeframe: within 14 days after Vaccination 2

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N" signifies number of participants evaluable for this outcome measure.

Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).

Outcome measures

PRIMARY outcome

Timeframe: within 14 days after Vaccination 2

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N" signifies number of participants evaluable for this outcome measure.

Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).

Outcome measures

PRIMARY outcome

Timeframe: within 14 days after Vaccination 3

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N" signifies number of participants evaluable for this outcome measure.

Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).

Outcome measures

PRIMARY outcome

Timeframe: within 14 days after Vaccination 3

Population: Safety population: all participants who received at least 1 dose of the investigational product. Here "N" signifies number of participants evaluable for this outcome measure.

Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).

Outcome measures

PRIMARY outcome

Timeframe: From Vaccination 1 up to 28 days after Vaccination 3 (Day 58)

Population: Safety population: all participants who received at least 1 dose of the investigational product.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=61 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=182 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=184 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs)	27.9 percentage of participants	23.6 percentage of participants	36.4 percentage of participants	—

PRIMARY outcome

Timeframe: From Vaccination 1 up to 28 days after Vaccination 3 (Day 208)

Population: Safety population: all participants who received at least 1 dose of the investigational product.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=61 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=183 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=183 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs)	54.1 percentage of participants	53.6 percentage of participants	55.7 percentage of participants	—

PRIMARY outcome

Timeframe: From Vaccination 1 up to 6 months after Vaccination 3 (Month 7)

Population: Safety population: all participants who received at least 1 dose of the investigational product.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events between first dose of study drug and up to 6 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=61 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=182 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=184 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs)	0.0 percentage of participants	6.0 percentage of participants	3.3 percentage of participants	—

PRIMARY outcome

Timeframe: From Vaccination 1 up to 6 months after Vaccination 3 (Month 12)

Population: Safety population: all participants who received at least 1 dose of the investigational product.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=61 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=183 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=183 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs)	3.3 percentage of participants	10.4 percentage of participants	12.0 percentage of participants	—

SECONDARY outcome

Timeframe: Day 1, 8, 15, 30 and Month 2, 4, 7, 13

Population: Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.

Toxin A antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=165 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 Day 1	0.0 percentage of participants Interval 0.0 to 6.4	1.2 percentage of participants Interval 0.1 to 4.2	0.6 percentage of participants Interval 0.0 to 3.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 Day 8	0.0 percentage of participants Interval 0.0 to 6.4	4.7 percentage of participants Interval 2.0 to 9.0	6.7 percentage of participants Interval 3.4 to 11.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 Day 15	0.0 percentage of participants Interval 0.0 to 6.4	17.0 percentage of participants Interval 11.7 to 23.4	25.0 percentage of participants Interval 18.6 to 32.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 Day 30	0.0 percentage of participants Interval 0.0 to 6.4	26.3 percentage of participants Interval 19.9 to 33.6	36.6 percentage of participants Interval 29.2 to 44.5	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 Month 2	3.6 percentage of participants Interval 0.4 to 12.3	61.4 percentage of participants Interval 53.7 to 68.7	85.5 percentage of participants Interval 79.1 to 90.5	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 Month 4	1.8 percentage of participants Interval 0.0 to 9.7	29.4 percentage of participants Interval 22.7 to 36.9	52.4 percentage of participants Interval 44.5 to 60.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 Month 7	0.0 percentage of participants Interval 0.0 to 6.6	15.1 percentage of participants Interval 10.0 to 21.4	31.4 percentage of participants Interval 24.3 to 39.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 Month 13	1.9 percentage of participants Interval 0.0 to 9.9	10.1 percentage of participants Interval 5.9 to 15.9	25.8 percentage of participants Interval 19.1 to 33.4	—

SECONDARY outcome

Timeframe: Day 1, 8, 15, 30 and Month 2, 4, 7, 13

Toxin B antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=164 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Day 1	5.4 percentage of participants Interval 1.1 to 14.9	4.7 percentage of participants Interval 2.0 to 9.0	3.7 percentage of participants Interval 1.4 to 7.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Day 8	3.6 percentage of participants Interval 0.4 to 12.3	9.9 percentage of participants Interval 5.9 to 15.4	11.5 percentage of participants Interval 7.1 to 17.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Day 15	3.6 percentage of participants Interval 0.4 to 12.3	30.4 percentage of participants Interval 23.6 to 37.9	37.2 percentage of participants Interval 29.8 to 45.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Day 30	3.6 percentage of participants Interval 0.4 to 12.3	29.8 percentage of participants Interval 23.1 to 37.3	37.2 percentage of participants Interval 29.8 to 45.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Month 2	1.8 percentage of participants Interval 0.0 to 9.6	29.2 percentage of participants Interval 22.5 to 36.7	37.0 percentage of participants Interval 29.6 to 44.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Month 4	0.0 percentage of participants Interval 0.0 to 6.5	26.5 percentage of participants Interval 20.0 to 33.8	31.1 percentage of participants Interval 24.1 to 38.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Month 7	0.0 percentage of participants Interval 0.0 to 6.6	24.1 percentage of participants Interval 17.8 to 31.3	26.4 percentage of participants Interval 19.7 to 34.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Month 13	1.9 percentage of participants Interval 0.0 to 9.9	19.6 percentage of participants Interval 13.7 to 26.7	31.0 percentage of participants Interval 23.8 to 38.9	—

SECONDARY outcome

Timeframe: Day 1, 8, 15, 30 and Month 2, 4, 7, 13

Toxin A and toxin B antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=164 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Day 1	0.0 percentage of participants Interval 0.0 to 6.4	0.0 percentage of participants Interval 0.0 to 2.1	0.0 percentage of participants Interval 0.0 to 2.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Day 8	0.0 percentage of participants Interval 0.0 to 6.4	3.5 percentage of participants Interval 1.3 to 7.5	4.8 percentage of participants Interval 2.1 to 9.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Day 15	0.0 percentage of participants Interval 0.0 to 6.4	11.7 percentage of participants Interval 7.3 to 17.5	18.3 percentage of participants Interval 12.7 to 25.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Day 30	0.0 percentage of participants Interval 0.0 to 6.4	15.8 percentage of participants Interval 10.7 to 22.1	20.7 percentage of participants Interval 14.8 to 27.7	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Month 2	0.0 percentage of participants Interval 0.0 to 6.4	24.0 percentage of participants Interval 17.8 to 31.1	36.4 percentage of participants Interval 29.0 to 44.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Month 4	0.0 percentage of participants Interval 0.0 to 6.5	13.5 percentage of participants Interval 8.8 to 19.6	24.4 percentage of participants Interval 18.0 to 31.7	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Month 7	0.0 percentage of participants Interval 0.0 to 6.6	8.4 percentage of participants Interval 4.7 to 13.7	15.7 percentage of participants Interval 10.4 to 22.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 Month 13	0.0 percentage of participants Interval 0.0 to 6.6	6.3 percentage of participants Interval 3.1 to 11.3	15.5 percentage of participants Interval 10.2 to 22.2	—

SECONDARY outcome

Timeframe: Day 1, 30, 37, 187 and Month 2, 6, 12, 18

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

Toxin A antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 1	1.9 percentage of participants Interval 0.0 to 10.1	0.6 percentage of participants Interval 0.0 to 3.4	1.3 percentage of participants Interval 0.2 to 4.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 30	0.0 percentage of participants Interval 0.0 to 6.7	17.3 percentage of participants Interval 11.8 to 24.0	19.1 percentage of participants Interval 13.3 to 26.1	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 37	1.9 percentage of participants Interval 0.0 to 10.1	43.6 percentage of participants Interval 35.8 to 51.5	56.7 percentage of participants Interval 48.6 to 64.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 2	1.9 percentage of participants Interval 0.0 to 10.1	41.1 percentage of participants Interval 33.5 to 49.1	57.0 percentage of participants Interval 48.9 to 64.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 6	1.9 percentage of participants Interval 0.0 to 10.1	15.3 percentage of participants Interval 10.2 to 21.8	20.3 percentage of participants Interval 14.3 to 27.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 187	0.0 percentage of participants Interval 0.0 to 6.7	80.2 percentage of participants Interval 73.3 to 86.1	84.8 percentage of participants Interval 78.2 to 90.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 12	2.0 percentage of participants Interval 0.0 to 10.4	71.9 percentage of participants Interval 64.2 to 78.7	77.4 percentage of participants Interval 70.0 to 83.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 18	3.9 percentage of participants Interval 0.5 to 13.5	48.7 percentage of participants Interval 40.6 to 56.9	53.3 percentage of participants Interval 45.0 to 61.4	—

SECONDARY outcome

Timeframe: Day 1, 30, 37, 187 and Month 2, 6, 12, 18

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

Toxin B antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 1	3.8 percentage of participants Interval 0.5 to 13.0	2.5 percentage of participants Interval 0.7 to 6.2	4.4 percentage of participants Interval 1.8 to 8.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 30	1.9 percentage of participants Interval 0.0 to 10.1	25.9 percentage of participants Interval 19.4 to 33.4	36.9 percentage of participants Interval 29.4 to 45.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 37	3.8 percentage of participants Interval 0.5 to 13.0	28.8 percentage of participants Interval 22.0 to 36.4	38.2 percentage of participants Interval 30.6 to 46.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 2	5.7 percentage of participants Interval 1.2 to 15.7	28.8 percentage of participants Interval 22.0 to 36.4	36.7 percentage of participants Interval 29.2 to 44.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 6	0.0 percentage of participants Interval 0.0 to 6.7	19.6 percentage of participants Interval 13.8 to 26.6	27.8 percentage of participants Interval 21.0 to 35.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 187	1.9 percentage of participants Interval 0.0 to 10.1	58.0 percentage of participants Interval 50.0 to 65.7	63.9 percentage of participants Interval 55.9 to 71.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 12	5.9 percentage of participants Interval 1.2 to 16.2	44.4 percentage of participants Interval 36.5 to 52.4	56.8 percentage of participants Interval 48.6 to 64.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 18	7.8 percentage of participants Interval 2.2 to 18.9	34.4 percentage of participants Interval 27.0 to 42.5	47.4 percentage of participants Interval 39.2 to 55.6	—

SECONDARY outcome

Timeframe: Day 1, 30, 37, 187 and Month 2, 6, 12, 18

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

Toxin A and toxin B antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 1	0.0 percentage of participants Interval 0.0 to 6.7	0.0 percentage of participants Interval 0.0 to 2.2	0.0 percentage of participants Interval 0.0 to 2.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 30	0.0 percentage of participants Interval 0.0 to 6.7	10.5 percentage of participants Interval 6.2 to 16.3	13.4 percentage of participants Interval 8.5 to 19.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 37	0.0 percentage of participants Interval 0.0 to 6.7	19.6 percentage of participants Interval 13.8 to 26.6	27.4 percentage of participants Interval 20.6 to 35.1	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 2	1.9 percentage of participants Interval 0.0 to 10.1	20.2 percentage of participants Interval 14.4 to 27.2	27.8 percentage of participants Interval 21.0 to 35.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 6	0.0 percentage of participants Interval 0.0 to 6.7	10.4 percentage of participants Interval 6.2 to 16.2	11.4 percentage of participants Interval 6.9 to 17.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Day 187	0.0 percentage of participants Interval 0.0 to 6.7	54.9 percentage of participants Interval 46.9 to 62.8	63.3 percentage of participants Interval 55.3 to 70.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 12	2.0 percentage of participants Interval 0.0 to 10.4	40.6 percentage of participants Interval 32.9 to 48.7	50.3 percentage of participants Interval 42.2 to 58.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 Month 18	0.0 percentage of participants Interval 0.0 to 7.0	26.6 percentage of participants Interval 19.8 to 34.3	32.9 percentage of participants Interval 25.5 to 41.0	—

SECONDARY outcome

Timeframe: Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13

Geometric mean concentration (GMC) of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. Confidence interval (CI) for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=165 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8	88 neutralization units/mL Interval 82.0 to 95.3	98 neutralization units/mL Interval 87.3 to 110.7	104 neutralization units/mL Interval 90.7 to 119.1	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15	81 neutralization units/mL Interval 78.1 to 84.5	143 neutralization units/mL Interval 121.3 to 169.1	192 neutralization units/mL Interval 152.9 to 241.5	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30	89 neutralization units/mL Interval 82.7 to 96.3	168 neutralization units/mL Interval 141.2 to 200.1	230 neutralization units/mL Interval 186.8 to 282.4	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2	95 neutralization units/mL Interval 85.7 to 105.5	295 neutralization units/mL Interval 255.3 to 340.4	484 neutralization units/mL Interval 415.9 to 562.8	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4	85 neutralization units/mL Interval 79.0 to 90.6	153 neutralization units/mL Interval 133.8 to 175.7	238 neutralization units/mL Interval 206.5 to 274.1	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 1	86 neutralization units/mL Interval 80.4 to 91.3	83 neutralization units/mL Interval 80.4 to 85.2	85 neutralization units/mL Interval 81.8 to 88.5	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37	102 neutralization units/mL Interval 88.4 to 118.7	368 neutralization units/mL Interval 314.6 to 431.4	556 neutralization units/mL Interval 480.0 to 644.2	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7	81 neutralization units/mL Interval 78.1 to 84.8	118 neutralization units/mL Interval 105.0 to 133.1	166 neutralization units/mL Interval 143.7 to 191.2	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13	89 neutralization units/mL Interval 80.9 to 96.8	105 neutralization units/mL Interval 94.7 to 116.5	138 neutralization units/mL Interval 119.9 to 159.8	—

SECONDARY outcome

Timeframe: Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13

GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=165 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15	190 neutralization units/mL Interval 148.7 to 241.7	807 neutralization units/mL Interval 551.7 to 1180.9	1091 neutralization units/mL Interval 720.1 to 1652.9	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13	178 neutralization units/mL Interval 142.6 to 221.5	447 neutralization units/mL Interval 350.1 to 569.8	828 neutralization units/mL Interval 618.2 to 1110.2	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 1	193 neutralization units/mL Interval 150.5 to 247.2	187 neutralization units/mL Interval 162.8 to 215.4	188 neutralization units/mL Interval 162.5 to 217.8	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8	190 neutralization units/mL Interval 149.6 to 241.6	273 neutralization units/mL Interval 215.5 to 345.1	290 neutralization units/mL Interval 226.5 to 372.5	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30	211 neutralization units/mL Interval 152.7 to 292.9	705 neutralization units/mL Interval 498.4 to 997.0	1029 neutralization units/mL Interval 688.4 to 1539.1	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37	180 neutralization units/mL Interval 142.3 to 227.1	728 neutralization units/mL Interval 520.8 to 1017.4	1219 neutralization units/mL Interval 831.1 to 1787.5	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2	188 neutralization units/mL Interval 147.0 to 239.3	676 neutralization units/mL Interval 490.0 to 933.6	1125 neutralization units/mL Interval 786.5 to 1608.7	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4	181 neutralization units/mL Interval 143.9 to 226.9	513 neutralization units/mL Interval 389.0 to 676.7	836 neutralization units/mL Interval 608.1 to 1150.0	—
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7	179 neutralization units/mL Interval 144.1 to 222.7	475 neutralization units/mL Interval 368.3 to 612.2	755 neutralization units/mL Interval 559.9 to 1018.5	—

SECONDARY outcome

Timeframe: Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

GMC of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187	80 neutralization units/mL Interval 77.9 to 82.3	500 neutralization units/mL Interval 422.6 to 591.3	744 neutralization units/mL Interval 618.9 to 894.5	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 1	83 neutralization units/mL Interval 78.3 to 88.9	85 neutralization units/mL Interval 82.3 to 88.6	87 neutralization units/mL Interval 83.1 to 91.2	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30	82 neutralization units/mL Interval 77.9 to 85.6	137 neutralization units/mL Interval 115.2 to 163.7	149 neutralization units/mL Interval 122.7 to 181.7	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37	93 neutralization units/mL Interval 85.1 to 102.6	231 neutralization units/mL Interval 191.6 to 277.3	329 neutralization units/mL Interval 270.6 to 400.2	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2	83 neutralization units/mL Interval 78.1 to 89.0	214 neutralization units/mL Interval 180.7 to 253.8	301 neutralization units/mL Interval 250.6 to 362.7	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6	84 neutralization units/mL Interval 79.0 to 89.6	115 neutralization units/mL Interval 101.5 to 129.5	136 neutralization units/mL Interval 116.4 to 158.2	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7	90 neutralization units/mL Interval 81.9 to 99.0	1245 neutralization units/mL Interval 1102.2 to 1405.6	1380 neutralization units/mL Interval 1198.6 to 1589.5	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12	89 neutralization units/mL Interval 79.6 to 99.2	378 neutralization units/mL Interval 323.2 to 441.9	473 neutralization units/mL Interval 402.1 to 556.2	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18	89 neutralization units/mL Interval 81.5 to 97.8	214 neutralization units/mL Interval 182.1 to 250.7	257 neutralization units/mL Interval 216.0 to 305.2	—

SECONDARY outcome

Timeframe: Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30	209 neutralization units/mL Interval 159.1 to 273.9	570 neutralization units/mL Interval 410.2 to 791.1	909 neutralization units/mL Interval 624.3 to 1324.6	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2	216 neutralization units/mL Interval 160.7 to 289.4	656 neutralization units/mL Interval 473.1 to 909.0	1029 neutralization units/mL Interval 718.2 to 1473.0	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7	229 neutralization units/mL Interval 168.0 to 310.9	6255 neutralization units/mL Interval 4971.0 to 7870.5	9549 neutralization units/mL Interval 7691.2 to 11856.0	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12	247 neutralization units/mL Interval 174.2 to 349.4	1799 neutralization units/mL Interval 1431.5 to 2260.1	2993 neutralization units/mL Interval 2365.7 to 3786.0	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 1	231 neutralization units/mL Interval 172.6 to 308.6	177 neutralization units/mL Interval 154.7 to 201.5	191 neutralization units/mL Interval 163.4 to 223.4	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37	218 neutralization units/mL Interval 164.7 to 288.6	662 neutralization units/mL Interval 472.4 to 928.0	1071 neutralization units/mL Interval 738.0 to 1553.2	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6	214 neutralization units/mL Interval 163.4 to 279.8	447 neutralization units/mL Interval 340.7 to 586.7	702 neutralization units/mL Interval 515.4 to 955.2	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187	199 neutralization units/mL Interval 155.0 to 255.1	2805 neutralization units/mL Interval 2162.7 to 3636.9	4669 neutralization units/mL Interval 3585.5 to 6079.0	—
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18	263 neutralization units/mL Interval 187.4 to 370.1	1248 neutralization units/mL Interval 970.6 to 1604.0	2178 neutralization units/mL Interval 1661.6 to 2856.1	—

SECONDARY outcome

Timeframe: Day 8, 15, 30, 37 and Month 2, 4, 7, 13

Geometric mean fold rise (GMFR) in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=165 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8	1.03 fold rise Interval 0.95 to 1.13	1.19 fold rise Interval 1.06 to 1.33	1.22 fold rise Interval 1.07 to 1.4	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15	0.95 fold rise Interval 0.89 to 1.01	1.73 fold rise Interval 1.47 to 2.04	2.27 fold rise Interval 1.8 to 2.86	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30	1.04 fold rise Interval 0.95 to 1.14	2.03 fold rise Interval 1.71 to 2.41	2.72 fold rise Interval 2.2 to 3.35	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37	1.20 fold rise Interval 1.03 to 1.39	4.45 fold rise Interval 3.81 to 5.2	6.56 fold rise Interval 5.65 to 7.62	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2	1.11 fold rise Interval 0.99 to 1.25	3.56 fold rise Interval 3.09 to 4.1	5.71 fold rise Interval 4.89 to 6.67	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4	0.99 fold rise Interval 0.91 to 1.06	1.85 fold rise Interval 1.62 to 2.12	2.81 fold rise Interval 2.44 to 3.25	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7	0.95 fold rise Interval 0.89 to 1.01	1.43 fold rise Interval 1.27 to 1.6	1.95 fold rise Interval 1.68 to 2.26	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13	1.03 fold rise Interval 0.92 to 1.15	1.26 fold rise Interval 1.14 to 1.4	1.64 fold rise Interval 1.42 to 1.9	—

SECONDARY outcome

Timeframe: Day 8, 15, 30, 37 and Month 2, 4, 7, 13

GMFR in toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=164 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8	0.99 fold rise Interval 0.94 to 1.04	1.46 fold rise Interval 1.24 to 1.72	1.55 fold rise Interval 1.31 to 1.84	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15	0.98 fold rise Interval 0.94 to 1.03	4.31 fold rise Interval 3.17 to 5.87	5.86 fold rise Interval 4.07 to 8.43	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30	1.10 fold rise Interval 0.86 to 1.39	3.76 fold rise Interval 2.87 to 4.94	5.53 fold rise Interval 3.89 to 7.85	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37	0.93 fold rise Interval 0.84 to 1.04	3.89 fold rise Interval 2.99 to 5.05	6.57 fold rise Interval 4.74 to 9.1	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2	0.97 fold rise Interval 0.9 to 1.05	3.61 fold rise Interval 2.82 to 4.63	6.06 fold rise Interval 4.5 to 8.15	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7	0.96 fold rise Interval 0.88 to 1.04	2.52 fold rise Interval 2.09 to 3.03	4.05 fold rise Interval 3.2 to 5.12	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13	0.95 fold rise Interval 0.87 to 1.04	2.40 fold rise Interval 2.0 to 2.89	4.44 fold rise Interval 3.46 to 5.69	—
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4	0.93 fold rise Interval 0.84 to 1.02	2.73 fold rise Interval 2.23 to 3.35	4.55 fold rise Interval 3.53 to 5.86	—

SECONDARY outcome

Timeframe: Day 30, 37, 187 and Month 2, 6, 7, 12, 18

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

GMFR in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30	0.98 fold rise Interval 0.9 to 1.06	1.61 fold rise Interval 1.35 to 1.91	1.71 fold rise Interval 1.41 to 2.09	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37	1.12 fold rise Interval 0.99 to 1.26	2.70 fold rise Interval 2.25 to 3.24	3.78 fold rise Interval 3.1 to 4.59	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2	1.00 fold rise Interval 0.91 to 1.1	2.51 fold rise Interval 2.12 to 2.97	3.46 fold rise Interval 2.88 to 4.16	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6	1.01 fold rise Interval 0.92 to 1.11	1.34 fold rise Interval 1.19 to 1.52	1.56 fold rise Interval 1.34 to 1.81	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187	0.96 fold rise Interval 0.89 to 1.03	5.85 fold rise Interval 4.92 to 6.95	8.54 fold rise Interval 7.08 to 10.3	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7	1.08 fold rise Interval 0.96 to 1.22	14.58 fold rise Interval 12.82 to 16.58	15.85 fold rise Interval 13.7 to 18.34	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12	1.06 fold rise Interval 0.93 to 1.21	4.42 fold rise Interval 3.77 to 5.19	5.45 fold rise Interval 4.62 to 6.42	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18	1.07 fold rise Interval 0.95 to 1.2	2.51 fold rise Interval 2.14 to 2.95	2.95 fold rise Interval 2.49 to 3.5	—

SECONDARY outcome

Timeframe: Day 30, 37, 187 and Month 2, 6, 7, 12, 18

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

GMFR for toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12	1.04 fold rise Interval 0.84 to 1.3	10.19 fold rise Interval 8.32 to 12.49	15.54 fold rise Interval 12.61 to 19.13	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30	0.90 fold rise Interval 0.74 to 1.1	3.28 fold rise Interval 2.48 to 4.35	4.75 fold rise Interval 3.47 to 6.5	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37	0.94 fold rise Interval 0.79 to 1.13	3.75 fold rise Interval 2.85 to 4.94	5.59 fold rise Interval 4.16 to 7.51	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2	0.93 fold rise Interval 0.74 to 1.18	3.71 fold rise Interval 2.83 to 4.87	5.38 fold rise Interval 4.05 to 7.15	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6	0.93 fold rise Interval 0.76 to 1.13	2.53 fold rise Interval 2.06 to 3.12	3.67 fold rise Interval 2.9 to 4.65	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187	0.86 fold rise Interval 0.72 to 1.03	15.85 fold rise Interval 12.54 to 20.05	24.44 fold rise Interval 19.14 to 31.2	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7	0.99 fold rise Interval 0.81 to 1.21	35.43 fold rise Interval 28.35 to 44.27	49.98 fold rise Interval 40.24 to 62.07	—
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18	1.11 fold rise Interval 0.9 to 1.39	7.07 fold rise Interval 5.69 to 8.77	11.21 fold rise Interval 8.85 to 14.21	—

SECONDARY outcome

Timeframe: Day 8, 15, 30, 37 and Month 2, 4, 7, 13

Toxin A antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=164 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	3.5 percentage of participants Interval 1.3 to 7.5	4.9 percentage of participants Interval 2.1 to 9.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	2.9 percentage of participants Interval 1.0 to 6.7	4.3 percentage of participants Interval 1.7 to 8.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	2.3 percentage of participants Interval 0.6 to 5.9	3.0 percentage of participants Interval 1.0 to 7.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	2.3 percentage of participants Interval 0.6 to 5.9	2.4 percentage of participants Interval 0.7 to 6.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	14.6 percentage of participants Interval 9.7 to 20.8	19.6 percentage of participants Interval 13.8 to 26.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	9.9 percentage of participants Interval 5.9 to 15.4	17.8 percentage of participants Interval 12.3 to 24.5	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	5.8 percentage of participants Interval 2.8 to 10.5	14.1 percentage of participants Interval 9.2 to 20.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=4 fold rise	1.8 percentage of participants Interval 0.0 to 9.6	32.7 percentage of participants Interval 25.8 to 40.3	59.1 percentage of participants Interval 51.2 to 66.7	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	18.1 percentage of participants Interval 12.7 to 24.7	31.1 percentage of participants Interval 24.1 to 38.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	5.8 percentage of participants Interval 2.8 to 10.5	12.8 percentage of participants Interval 8.1 to 18.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	3.5 percentage of participants Interval 1.3 to 7.5	6.7 percentage of participants Interval 3.4 to 11.7	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	1.8 percentage of participants Interval 0.4 to 5.2	5.7 percentage of participants Interval 2.6 to 10.5	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 2.2	1.3 percentage of participants Interval 0.2 to 4.5	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=4 fold rise	1.9 percentage of participants Interval 0.0 to 9.9	6.3 percentage of participants Interval 3.1 to 11.3	16.2 percentage of participants Interval 10.8 to 23.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	3.8 percentage of participants Interval 1.4 to 8.1	9.7 percentage of participants Interval 5.6 to 15.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	0.6 percentage of participants Interval 0.0 to 3.5	3.2 percentage of participants Interval 1.1 to 7.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	4.7 percentage of participants Interval 2.0 to 9.0	9.2 percentage of participants Interval 5.2 to 14.7	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	17.5 percentage of participants Interval 12.2 to 24.1	25.8 percentage of participants Interval 19.2 to 33.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	8.2 percentage of participants Interval 4.5 to 13.4	17.2 percentage of participants Interval 11.7 to 23.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	5.8 percentage of participants Interval 2.8 to 10.5	13.5 percentage of participants Interval 8.7 to 19.7	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	5.3 percentage of participants Interval 2.4 to 9.8	8.6 percentage of participants Interval 4.8 to 14.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=4 fold rise	5.4 percentage of participants Interval 1.1 to 14.9	46.8 percentage of participants Interval 39.1 to 54.6	65.2 percentage of participants Interval 57.4 to 72.5	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	25.1 percentage of participants Interval 18.8 to 32.3	40.9 percentage of participants Interval 33.3 to 48.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	8.8 percentage of participants Interval 5.0 to 14.1	14.0 percentage of participants Interval 9.1 to 20.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	3.5 percentage of participants Interval 1.3 to 7.5	8.5 percentage of participants Interval 4.7 to 13.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	13.5 percentage of participants Interval 8.8 to 19.6	24.5 percentage of participants Interval 18.1 to 31.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	7.1 percentage of participants Interval 3.7 to 12.0	12.9 percentage of participants Interval 8.2 to 19.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	4.1 percentage of participants Interval 1.7 to 8.3	5.5 percentage of participants Interval 2.6 to 10.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	1.2 percentage of participants Interval 0.1 to 4.2	2.5 percentage of participants Interval 0.7 to 6.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	9.0 percentage of participants Interval 5.1 to 14.5	16.5 percentage of participants Interval 11.0 to 23.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	5.4 percentage of participants Interval 2.5 to 10.0	10.1 percentage of participants Interval 5.9 to 15.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	0.6 percentage of participants Interval 0.0 to 3.5	0.6 percentage of participants Interval 0.0 to 3.6	—

SECONDARY outcome

Timeframe: Day 8, 15, 30, 37 and Month 2, 4, 7, 13

Toxin B antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=164 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	4.7 percentage of participants Interval 2.0 to 9.0	4.9 percentage of participants Interval 2.1 to 9.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	3.5 percentage of participants Interval 1.3 to 7.5	3.0 percentage of participants Interval 1.0 to 7.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	36.8 percentage of participants Interval 29.6 to 44.5	41.1 percentage of participants Interval 33.5 to 49.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	33.3 percentage of participants Interval 26.3 to 40.9	38.7 percentage of participants Interval 31.1 to 46.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	26.3 percentage of participants Interval 19.9 to 33.6	35.0 percentage of participants Interval 27.7 to 42.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	20.5 percentage of participants Interval 14.7 to 27.3	29.4 percentage of participants Interval 22.6 to 37.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=4 fold rise	1.8 percentage of participants Interval 0.0 to 9.6	39.2 percentage of participants Interval 31.8 to 46.9	42.3 percentage of participants Interval 34.6 to 50.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=8 fold rise	1.8 percentage of participants Interval 0.0 to 9.6	33.3 percentage of participants Interval 26.3 to 40.9	39.9 percentage of participants Interval 32.3 to 47.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=16 fold rise	1.8 percentage of participants Interval 0.0 to 9.6	22.8 percentage of participants Interval 16.7 to 29.8	37.4 percentage of participants Interval 30.0 to 45.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	41.5 percentage of participants Interval 34.0 to 49.3	46.3 percentage of participants Interval 38.5 to 54.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	33.9 percentage of participants Interval 26.9 to 41.5	40.2 percentage of participants Interval 32.7 to 48.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	24.0 percentage of participants Interval 17.8 to 31.1	37.2 percentage of participants Interval 29.8 to 45.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	16.4 percentage of participants Interval 11.2 to 22.8	27.4 percentage of participants Interval 20.8 to 34.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	39.2 percentage of participants Interval 31.8 to 46.9	46.3 percentage of participants Interval 38.5 to 54.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	32.2 percentage of participants Interval 25.2 to 39.7	38.4 percentage of participants Interval 30.9 to 46.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	22.8 percentage of participants Interval 16.7 to 29.8	34.1 percentage of participants Interval 26.9 to 41.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	14.6 percentage of participants Interval 9.7 to 20.8	24.4 percentage of participants Interval 18.0 to 31.7	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	35.9 percentage of participants Interval 28.7 to 43.6	42.3 percentage of participants Interval 34.6 to 50.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	23.5 percentage of participants Interval 17.4 to 30.6	34.4 percentage of participants Interval 27.1 to 42.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	14.7 percentage of participants Interval 9.7 to 20.9	25.8 percentage of participants Interval 19.2 to 33.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	5.9 percentage of participants Interval 2.9 to 10.6	16.6 percentage of participants Interval 11.2 to 23.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	34.9 percentage of participants Interval 27.7 to 42.7	45.6 percentage of participants Interval 37.6 to 53.7	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	19.9 percentage of participants Interval 14.1 to 26.8	30.4 percentage of participants Interval 23.3 to 38.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	8.4 percentage of participants Interval 4.7 to 13.7	20.3 percentage of participants Interval 14.3 to 27.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	1.8 percentage of participants Interval 0.4 to 5.2	13.3 percentage of participants Interval 8.4 to 19.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	35.4 percentage of participants Interval 28.0 to 43.4	46.8 percentage of participants Interval 38.7 to 55.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	17.7 percentage of participants Interval 12.1 to 24.6	30.5 percentage of participants Interval 23.4 to 38.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	10.8 percentage of participants Interval 6.4 to 16.7	20.8 percentage of participants Interval 14.7 to 28.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	1.3 percentage of participants Interval 0.2 to 4.5	14.9 percentage of participants Interval 9.7 to 21.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	11.7 percentage of participants Interval 7.3 to 17.5	14.6 percentage of participants Interval 9.6 to 21.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	8.2 percentage of participants Interval 4.5 to 13.4	8.5 percentage of participants Interval 4.7 to 13.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=32 fold rise	1.8 percentage of participants Interval 0.0 to 9.6	17.0 percentage of participants Interval 11.7 to 23.4	27.6 percentage of participants Interval 20.9 to 35.1	—

SECONDARY outcome

Timeframe: Day 8, 15, 30, 37 and Month 2, 4, 7, 13

Toxin A and toxin B antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=56 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=171 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=164 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	3.5 percentage of participants Interval 1.3 to 7.5	3.0 percentage of participants Interval 1.0 to 7.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	2.9 percentage of participants Interval 1.0 to 6.7	1.8 percentage of participants Interval 0.4 to 5.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	2.3 percentage of participants Interval 0.6 to 5.9	1.2 percentage of participants Interval 0.1 to 4.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 8: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	1.8 percentage of participants Interval 0.4 to 5.0	0.6 percentage of participants Interval 0.0 to 3.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	7.6 percentage of participants Interval 4.1 to 12.6	14.7 percentage of participants Interval 9.7 to 21.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	4.7 percentage of participants Interval 2.0 to 9.0	9.8 percentage of participants Interval 5.7 to 15.5	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	2.9 percentage of participants Interval 1.0 to 6.7	10.4 percentage of participants Interval 6.2 to 16.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	2.3 percentage of participants Interval 0.6 to 5.9	5.5 percentage of participants Interval 2.5 to 10.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	12.3 percentage of participants Interval 7.8 to 18.2	17.2 percentage of participants Interval 11.7 to 23.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 15: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	3.5 percentage of participants Interval 1.3 to 7.5	4.9 percentage of participants Interval 2.1 to 9.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	13.5 percentage of participants Interval 8.7 to 19.5	20.2 percentage of participants Interval 14.4 to 27.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	7.0 percentage of participants Interval 3.7 to 11.9	14.1 percentage of participants Interval 9.2 to 20.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	4.1 percentage of participants Interval 1.7 to 8.3	11.0 percentage of participants Interval 6.7 to 16.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 30: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	3.5 percentage of participants Interval 1.3 to 7.5	5.5 percentage of participants Interval 2.6 to 10.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	25.1 percentage of participants Interval 18.8 to 32.3	36.0 percentage of participants Interval 28.6 to 43.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	14.6 percentage of participants Interval 9.7 to 20.8	25.6 percentage of participants Interval 19.1 to 33.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	6.4 percentage of participants Interval 3.3 to 11.2	11.6 percentage of participants Interval 7.1 to 17.5	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Day 37: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	2.3 percentage of participants Interval 0.6 to 5.9	6.7 percentage of participants Interval 3.4 to 11.7	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	21.6 percentage of participants Interval 15.7 to 28.6	34.8 percentage of participants Interval 27.5 to 42.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 2: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.4	11.7 percentage of participants Interval 7.3 to 17.5	21.3 percentage of participants Interval 15.3 to 28.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	8.8 percentage of participants Interval 5.0 to 14.1	19.0 percentage of participants Interval 13.3 to 25.9	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	4.1 percentage of participants Interval 1.7 to 8.3	9.2 percentage of participants Interval 5.2 to 14.7	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	2.4 percentage of participants Interval 0.6 to 5.9	3.1 percentage of participants Interval 1.0 to 7.0	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 4: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.5	0.6 percentage of participants Interval 0.0 to 3.2	1.2 percentage of participants Interval 0.1 to 4.4	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	7.2 percentage of participants Interval 3.8 to 12.3	13.9 percentage of participants Interval 8.9 to 20.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	3.6 percentage of participants Interval 1.3 to 7.7	7.0 percentage of participants Interval 3.5 to 12.1	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	0.6 percentage of participants Interval 0.0 to 3.3	3.2 percentage of participants Interval 1.0 to 7.2	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 7: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 0.6	0.0 percentage of participants Interval 0.0 to 2.2	0.0 percentage of participants Interval 0.0 to 2.3	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	5.1 percentage of participants Interval 2.2 to 9.7	14.3 percentage of participants Interval 9.2 to 20.8	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	2.5 percentage of participants Interval 0.7 to 6.4	6.5 percentage of participants Interval 3.2 to 11.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 2.3	1.3 percentage of participants Interval 0.2 to 4.6	—
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 Month 13: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 2.3	0.0 percentage of participants Interval 0.0 to 2.4	—

SECONDARY outcome

Timeframe: Day 30, 37, 187 and Month 2, 6, 7, 12, 18

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

Toxin A antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	14.2 percentage of participants Interval 9.2 to 20.5	14.0 percentage of participants Interval 9.0 to 20.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	12.3 percentage of participants Interval 7.7 to 18.4	11.5 percentage of participants Interval 6.9 to 17.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	6.8 percentage of participants Interval 3.4 to 11.8	10.2 percentage of participants Interval 5.9 to 16.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	2.5 percentage of participants Interval 0.7 to 6.2	6.4 percentage of participants Interval 3.1 to 11.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	28.2 percentage of participants Interval 21.5 to 35.8	40.1 percentage of participants Interval 32.4 to 48.2	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	16.0 percentage of participants Interval 10.7 to 22.5	26.8 percentage of participants Interval 20.0 to 34.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	6.1 percentage of participants Interval 3.0 to 11.0	12.7 percentage of participants Interval 8.0 to 19.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	3.1 percentage of participants Interval 1.0 to 7.0	7.0 percentage of participants Interval 3.5 to 12.2	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=4 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	28.2 percentage of participants Interval 21.5 to 35.8	36.1 percentage of participants Interval 28.6 to 44.1	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	14.7 percentage of participants Interval 9.7 to 21.1	21.5 percentage of participants Interval 15.4 to 28.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	6.7 percentage of participants Interval 3.4 to 11.8	12.0 percentage of participants Interval 7.4 to 18.1	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	2.5 percentage of participants Interval 0.7 to 6.2	7.0 percentage of participants Interval 3.5 to 12.1	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	9.2 percentage of participants Interval 5.2 to 14.7	12.7 percentage of participants Interval 7.9 to 18.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	6.1 percentage of participants Interval 3.0 to 11.0	10.1 percentage of participants Interval 5.9 to 15.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	1.2 percentage of participants Interval 0.1 to 4.4	5.1 percentage of participants Interval 2.2 to 9.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	0.6 percentage of participants Interval 0.0 to 3.4	2.5 percentage of participants Interval 0.7 to 6.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	63.0 percentage of participants Interval 55.0 to 70.4	71.5 percentage of participants Interval 63.8 to 78.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	43.8 percentage of participants Interval 36.1 to 51.8	55.7 percentage of participants Interval 47.6 to 63.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	16.7 percentage of participants Interval 11.3 to 23.3	32.9 percentage of participants Interval 25.7 to 40.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	5.6 percentage of participants Interval 2.6 to 10.3	13.3 percentage of participants Interval 8.4 to 19.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=4 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	91.4 percentage of participants Interval 86.0 to 95.2	91.8 percentage of participants Interval 86.3 to 95.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	76.7 percentage of participants Interval 69.4 to 82.9	78.5 percentage of participants Interval 71.2 to 84.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	47.2 percentage of participants Interval 39.4 to 55.2	56.3 percentage of participants Interval 48.2 to 64.2	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	20.2 percentage of participants Interval 14.4 to 27.2	21.5 percentage of participants Interval 15.4 to 28.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=4 fold rise	2.0 percentage of participants Interval 0.0 to 10.4	50.6 percentage of participants Interval 42.6 to 58.6	61.3 percentage of participants Interval 53.1 to 69.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=8 fold rise	2.0 percentage of participants Interval 0.0 to 10.4	27.5 percentage of participants Interval 20.7 to 35.1	40.6 percentage of participants Interval 32.8 to 48.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	9.4 percentage of participants Interval 5.3 to 15.0	14.2 percentage of participants Interval 9.1 to 20.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	2.5 percentage of participants Interval 0.7 to 6.3	1.9 percentage of participants Interval 0.4 to 5.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	27.9 percentage of participants Interval 21.0 to 35.7	39.5 percentage of participants Interval 31.6 to 47.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	13.6 percentage of participants Interval 8.6 to 20.1	20.4 percentage of participants Interval 14.3 to 27.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	5.8 percentage of participants Interval 2.7 to 10.8	7.2 percentage of participants Interval 3.7 to 12.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	1.3 percentage of participants Interval 0.2 to 4.6	0.0 percentage of participants Interval 0.0 to 2.4	—

SECONDARY outcome

Timeframe: Day 30, 37, 187 and Month 2, 6, 7, 12, 18

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

Toxin A antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=16 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	21.6 percentage of participants Interval 15.5 to 28.7	30.6 percentage of participants Interval 23.5 to 38.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	16.7 percentage of participants Interval 11.3 to 23.3	20.4 percentage of participants Interval 14.4 to 27.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=4 fold rise	3.8 percentage of participants Interval 0.5 to 13.0	37.4 percentage of participants Interval 30.0 to 45.3	47.5 percentage of participants Interval 39.5 to 55.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=4 fold rise	3.8 percentage of participants Interval 0.5 to 13.0	30.1 percentage of participants Interval 23.1 to 37.7	41.1 percentage of participants Interval 33.4 to 49.2	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=16 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	52.5 percentage of participants Interval 44.5 to 60.4	63.3 percentage of participants Interval 55.3 to 70.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=16 fold rise	3.9 percentage of participants Interval 0.5 to 13.5	39.4 percentage of participants Interval 31.8 to 47.4	51.6 percentage of participants Interval 43.5 to 59.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=4 fold rise	3.8 percentage of participants Interval 0.5 to 13.0	34.0 percentage of participants Interval 26.7 to 41.8	43.3 percentage of participants Interval 35.4 to 51.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=8 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	29.6 percentage of participants Interval 22.7 to 37.3	38.9 percentage of participants Interval 31.2 to 46.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=4 fold rise	3.8 percentage of participants Interval 0.5 to 13.0	36.8 percentage of participants Interval 29.4 to 44.7	47.8 percentage of participants Interval 39.7 to 55.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=8 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	30.7 percentage of participants Interval 23.7 to 38.4	42.7 percentage of participants Interval 34.8 to 50.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=16 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	23.9 percentage of participants Interval 17.6 to 31.2	33.1 percentage of participants Interval 25.8 to 41.1	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	18.4 percentage of participants Interval 12.8 to 25.2	22.3 percentage of participants Interval 16.0 to 29.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=8 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	32.5 percentage of participants Interval 25.4 to 40.3	39.9 percentage of participants Interval 32.2 to 48.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=16 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	23.3 percentage of participants Interval 17.1 to 30.6	29.7 percentage of participants Interval 22.7 to 37.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=32 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	16.6 percentage of participants Interval 11.2 to 23.2	23.4 percentage of participants Interval 17.1 to 30.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=8 fold rise	3.8 percentage of participants Interval 0.5 to 13.0	21.5 percentage of participants Interval 15.4 to 28.6	32.3 percentage of participants Interval 25.1 to 40.2	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=16 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	13.5 percentage of participants Interval 8.7 to 19.7	21.5 percentage of participants Interval 15.4 to 28.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	6.7 percentage of participants Interval 3.4 to 11.8	12.0 percentage of participants Interval 7.4 to 18.1	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=4 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	79.0 percentage of participants Interval 71.9 to 85.0	87.3 percentage of participants Interval 81.1 to 92.1	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=8 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	68.5 percentage of participants Interval 60.8 to 75.6	78.5 percentage of participants Interval 71.2 to 84.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	32.1 percentage of participants Interval 25.0 to 39.9	46.2 percentage of participants Interval 38.2 to 54.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=4 fold rise	3.8 percentage of participants Interval 0.5 to 13.0	92.0 percentage of participants Interval 86.7 to 95.7	93.7 percentage of participants Interval 88.7 to 96.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=8 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	84.7 percentage of participants Interval 78.2 to 89.8	90.5 percentage of participants Interval 84.8 to 94.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=16 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	76.1 percentage of participants Interval 68.8 to 82.4	83.5 percentage of participants Interval 76.8 to 89.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=32 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	55.8 percentage of participants Interval 47.9 to 63.6	66.5 percentage of participants Interval 58.5 to 73.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=4 fold rise	3.9 percentage of participants Interval 0.5 to 13.5	75.0 percentage of participants Interval 67.6 to 81.5	85.8 percentage of participants Interval 79.3 to 90.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=8 fold rise	3.9 percentage of participants Interval 0.5 to 13.5	59.4 percentage of participants Interval 51.3 to 67.1	73.5 percentage of participants Interval 65.9 to 80.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	18.1 percentage of participants Interval 12.5 to 25.0	27.1 percentage of participants Interval 20.3 to 34.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=4 fold rise	7.8 percentage of participants Interval 2.2 to 18.9	66.9 percentage of participants Interval 58.9 to 74.2	78.3 percentage of participants Interval 70.9 to 84.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=8 fold rise	3.9 percentage of participants Interval 0.5 to 13.5	44.2 percentage of participants Interval 36.2 to 52.4	60.5 percentage of participants Interval 52.3 to 68.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=16 fold rise	2.0 percentage of participants Interval 0.0 to 10.4	29.2 percentage of participants Interval 22.2 to 37.1	40.1 percentage of participants Interval 32.3 to 48.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	13.0 percentage of participants Interval 8.1 to 19.3	23.0 percentage of participants Interval 16.6 to 30.5	—

SECONDARY outcome

Timeframe: Day 30, 37, 187 and Month 2, 6, 7, 12, 18

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.

Toxin A and toxin B antibodies were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=53 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=163 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=158 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	9.2 percentage of participants Interval 5.2 to 14.7	19.7 percentage of participants Interval 13.8 to 26.8	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=4 fold rise	1.9 percentage of participants Interval 0.0 to 10.1	18.4 percentage of participants Interval 12.8 to 25.2	24.1 percentage of participants Interval 17.6 to 31.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	58.6 percentage of participants Interval 50.6 to 66.3	69.6 percentage of participants Interval 61.8 to 76.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	39.5 percentage of participants Interval 31.9 to 47.5	50.6 percentage of participants Interval 42.6 to 58.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	3.9 percentage of participants Interval 1.4 to 8.3	3.9 percentage of participants Interval 1.5 to 8.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	11.7 percentage of participants Interval 7.2 to 17.7	12.1 percentage of participants Interval 7.4 to 18.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	9.3 percentage of participants Interval 5.3 to 14.8	9.6 percentage of participants Interval 5.4 to 15.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	3.1 percentage of participants Interval 1.0 to 7.1	7.0 percentage of participants Interval 3.5 to 12.2	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 30: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	0.6 percentage of participants Interval 0.0 to 3.4	3.2 percentage of participants Interval 1.0 to 7.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	19.0 percentage of participants Interval 13.3 to 25.9	26.8 percentage of participants Interval 20.0 to 34.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	3.7 percentage of participants Interval 1.4 to 7.8	8.3 percentage of participants Interval 4.5 to 13.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 37: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	1.2 percentage of participants Interval 0.1 to 4.4	3.8 percentage of participants Interval 1.4 to 8.1	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	10.4 percentage of participants Interval 6.2 to 16.2	14.6 percentage of participants Interval 9.5 to 21.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	3.1 percentage of participants Interval 1.0 to 7.0	7.0 percentage of participants Interval 3.5 to 12.1	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 2: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	1.2 percentage of participants Interval 0.1 to 4.4	3.2 percentage of participants Interval 1.0 to 7.2	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	8.0 percentage of participants Interval 4.3 to 13.3	10.1 percentage of participants Interval 5.9 to 15.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	2.5 percentage of participants Interval 0.7 to 6.2	6.3 percentage of participants Interval 3.1 to 11.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	0.6 percentage of participants Interval 0.0 to 3.4	2.5 percentage of participants Interval 0.7 to 6.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 6: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	0.0 percentage of participants Interval 0.0 to 2.2	1.3 percentage of participants Interval 0.2 to 4.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	11.1 percentage of participants Interval 6.7 to 17.0	27.2 percentage of participants Interval 20.4 to 34.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Day 187: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	2.5 percentage of participants Interval 0.7 to 6.2	10.8 percentage of participants Interval 6.4 to 16.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	84.7 percentage of participants Interval 78.2 to 89.8	87.3 percentage of participants Interval 81.1 to 92.1	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	68.7 percentage of participants Interval 61.0 to 75.7	74.1 percentage of participants Interval 66.5 to 80.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	41.1 percentage of participants Interval 33.5 to 49.1	52.5 percentage of participants Interval 44.4 to 60.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 7: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 6.7	14.1 percentage of participants Interval 9.2 to 20.4	17.1 percentage of participants Interval 11.6 to 23.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	44.4 percentage of participants Interval 36.5 to 52.4	58.7 percentage of participants Interval 50.5 to 66.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	21.9 percentage of participants Interval 15.7 to 29.1	35.5 percentage of participants Interval 28.0 to 43.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	5.0 percentage of participants Interval 2.2 to 9.6	9.7 percentage of participants Interval 5.5 to 15.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 12: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	1.3 percentage of participants Interval 0.2 to 4.4	1.3 percentage of participants Interval 0.2 to 4.6	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	23.4 percentage of participants Interval 16.9 to 30.9	36.2 percentage of participants Interval 28.6 to 44.4	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	10.4 percentage of participants Interval 6.1 to 16.3	19.1 percentage of participants Interval 13.2 to 26.2	—
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 Month 18: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.0	0.6 percentage of participants Interval 0.0 to 3.6	0.0 percentage of participants Interval 0.0 to 2.4	—

SECONDARY outcome

Timeframe: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.

Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=16 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=18 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=24 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=20 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	7.1 percentage of participants Interval 0.2 to 33.9	76.5 percentage of participants Interval 50.1 to 93.2	10.0 percentage of participants Interval 1.2 to 31.7	94.4 percentage of participants Interval 72.7 to 99.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	7.7 percentage of participants Interval 0.2 to 36.0	87.5 percentage of participants Interval 61.7 to 98.4	10.0 percentage of participants Interval 1.2 to 31.7	94.4 percentage of participants Interval 72.7 to 99.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 1	6.3 percentage of participants Interval 0.2 to 30.2	22.2 percentage of participants Interval 6.4 to 47.6	20.8 percentage of participants Interval 7.1 to 42.2	30.0 percentage of participants Interval 11.9 to 54.3
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	6.3 percentage of participants Interval 0.2 to 30.2	100.0 percentage of participants Interval 81.5 to 100.0	12.5 percentage of participants Interval 2.7 to 32.4	100.0 percentage of participants Interval 83.2 to 100.0
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	6.3 percentage of participants Interval 0.2 to 30.2	100.0 percentage of participants Interval 81.5 to 100.0	29.2 percentage of participants Interval 12.6 to 51.1	100.0 percentage of participants Interval 83.2 to 100.0
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	6.3 percentage of participants Interval 0.2 to 30.2	100.0 percentage of participants Interval 81.5 to 100.0	21.7 percentage of participants Interval 7.5 to 43.7	100.0 percentage of participants Interval 83.2 to 100.0
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	6.3 percentage of participants Interval 0.2 to 30.2	88.9 percentage of participants Interval 65.3 to 98.6	14.3 percentage of participants Interval 3.0 to 36.3	95.0 percentage of participants Interval 75.1 to 99.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	12.5 percentage of participants Interval 1.6 to 38.3	82.4 percentage of participants Interval 56.6 to 96.2	15.0 percentage of participants Interval 3.2 to 37.9	95.0 percentage of participants Interval 75.1 to 99.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	6.3 percentage of participants Interval 0.2 to 30.2	82.4 percentage of participants Interval 56.6 to 96.2	5.0 percentage of participants Interval 0.1 to 24.9	84.2 percentage of participants Interval 60.4 to 96.6

SECONDARY outcome

Timeframe: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=16 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=18 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=24 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=20 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	6.3 percentage of participants Interval 0.2 to 30.2	94.4 percentage of participants Interval 72.7 to 99.9	21.7 percentage of participants Interval 7.5 to 43.7	85.0 percentage of participants Interval 62.1 to 96.8
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	0.0 percentage of participants Interval 0.0 to 20.6	64.7 percentage of participants Interval 38.3 to 85.8	25.0 percentage of participants Interval 8.7 to 49.1	78.9 percentage of participants Interval 54.4 to 93.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	0.0 percentage of participants Interval 0.0 to 24.7	75.0 percentage of participants Interval 47.6 to 92.7	25.0 percentage of participants Interval 8.7 to 49.1	77.8 percentage of participants Interval 52.4 to 93.6
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 1	12.5 percentage of participants Interval 1.6 to 38.3	44.4 percentage of participants Interval 21.5 to 69.2	29.2 percentage of participants Interval 12.6 to 51.1	40.0 percentage of participants Interval 19.1 to 63.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	12.5 percentage of participants Interval 1.6 to 38.3	88.9 percentage of participants Interval 65.3 to 98.6	25.0 percentage of participants Interval 9.8 to 46.7	95.0 percentage of participants Interval 75.1 to 99.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	12.5 percentage of participants Interval 1.6 to 38.3	100.0 percentage of participants Interval 81.5 to 100.0	25.0 percentage of participants Interval 9.8 to 46.7	95.0 percentage of participants Interval 75.1 to 99.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	6.3 percentage of participants Interval 0.2 to 30.2	88.9 percentage of participants Interval 65.3 to 98.6	19.0 percentage of participants Interval 5.4 to 41.9	85.0 percentage of participants Interval 62.1 to 96.8
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	0.0 percentage of participants Interval 0.0 to 20.6	82.4 percentage of participants Interval 56.6 to 96.2	30.0 percentage of participants Interval 11.9 to 54.3	75.0 percentage of participants Interval 50.9 to 91.3
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	0.0 percentage of participants Interval 0.0 to 23.2	70.6 percentage of participants Interval 44.0 to 89.7	25.0 percentage of participants Interval 8.7 to 49.1	77.8 percentage of participants Interval 52.4 to 93.6

SECONDARY outcome

Timeframe: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=16 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=18 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=24 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=20 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	0.0 percentage of participants Interval 0.0 to 20.6	94.4 percentage of participants Interval 72.7 to 99.9	8.7 percentage of participants Interval 1.1 to 28.0	85.0 percentage of participants Interval 62.1 to 96.8
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 1	0.0 percentage of participants Interval 0.0 to 20.6	11.1 percentage of participants Interval 1.4 to 34.7	8.3 percentage of participants Interval 1.0 to 27.0	15.0 percentage of participants Interval 3.2 to 37.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	0.0 percentage of participants Interval 0.0 to 20.6	88.9 percentage of participants Interval 65.3 to 98.6	4.2 percentage of participants Interval 0.1 to 21.1	95.0 percentage of participants Interval 75.1 to 99.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	0.0 percentage of participants Interval 0.0 to 20.6	100.0 percentage of participants Interval 81.5 to 100.0	8.3 percentage of participants Interval 1.0 to 27.0	95.0 percentage of participants Interval 75.1 to 99.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	0.0 percentage of participants Interval 0.0 to 20.6	83.3 percentage of participants Interval 58.6 to 96.4	9.5 percentage of participants Interval 1.2 to 30.4	80.0 percentage of participants Interval 56.3 to 94.3
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	0.0 percentage of participants Interval 0.0 to 20.6	70.6 percentage of participants Interval 44.0 to 89.7	10.0 percentage of participants Interval 1.2 to 31.7	75.0 percentage of participants Interval 50.9 to 91.3
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	0.0 percentage of participants Interval 0.0 to 20.6	52.9 percentage of participants Interval 27.8 to 77.0	0.0 percentage of participants Interval 0.0 to 16.8	73.7 percentage of participants Interval 48.8 to 90.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	0.0 percentage of participants Interval 0.0 to 23.2	58.8 percentage of participants Interval 32.9 to 81.6	10.0 percentage of participants Interval 1.2 to 31.7	72.2 percentage of participants Interval 46.5 to 90.3
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	0.0 percentage of participants Interval 0.0 to 24.7	68.8 percentage of participants Interval 41.3 to 89.0	10.0 percentage of participants Interval 1.2 to 31.7	77.8 percentage of participants Interval 52.4 to 93.6

SECONDARY outcome

Timeframe: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=48 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=52 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=58 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=59 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 1	54.2 percentage of participants Interval 39.2 to 68.6	32.7 percentage of participants Interval 20.3 to 47.1	50.0 percentage of participants Interval 36.6 to 63.4	61.0 percentage of participants Interval 47.4 to 73.5
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	50.0 percentage of participants Interval 35.2 to 64.8	94.2 percentage of participants Interval 84.1 to 98.8	53.4 percentage of participants Interval 39.9 to 66.7	94.9 percentage of participants Interval 85.9 to 98.9
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	37.5 percentage of participants Interval 24.0 to 52.6	100.0 percentage of participants Interval 93.2 to 100.0	56.9 percentage of participants Interval 43.2 to 69.8	100.0 percentage of participants Interval 93.9 to 100.0
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	40.4 percentage of participants Interval 26.4 to 55.7	98.0 percentage of participants Interval 89.4 to 99.9	47.4 percentage of participants Interval 34.0 to 61.0	96.6 percentage of participants Interval 88.3 to 99.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	34.8 percentage of participants Interval 21.4 to 50.2	88.0 percentage of participants Interval 75.7 to 95.5	47.3 percentage of participants Interval 33.7 to 61.2	96.6 percentage of participants Interval 88.1 to 99.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	20.5 percentage of participants Interval 9.8 to 35.3	73.5 percentage of participants Interval 58.9 to 85.1	25.9 percentage of participants Interval 15.0 to 39.7	91.4 percentage of participants Interval 81.0 to 97.1
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	38.6 percentage of participants Interval 24.4 to 54.5	68.8 percentage of participants Interval 53.7 to 81.3	37.7 percentage of participants Interval 24.8 to 52.1	77.2 percentage of participants Interval 64.2 to 87.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	19.5 percentage of participants Interval 8.8 to 34.9	60.0 percentage of participants Interval 44.3 to 74.3	29.4 percentage of participants Interval 17.5 to 43.8	72.7 percentage of participants Interval 59.0 to 83.9
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	22.0 percentage of participants Interval 10.6 to 37.6	45.5 percentage of participants Interval 30.4 to 61.2	24.0 percentage of participants Interval 13.1 to 38.2	71.7 percentage of participants Interval 57.7 to 83.2

SECONDARY outcome

Timeframe: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=48 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=52 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=58 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=59 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	50.0 percentage of participants Interval 34.6 to 65.4	31.3 percentage of participants Interval 18.7 to 46.3	35.8 percentage of participants Interval 23.1 to 50.2	52.6 percentage of participants Interval 39.0 to 66.0
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 1	39.6 percentage of participants Interval 25.8 to 54.7	15.4 percentage of participants Interval 6.9 to 28.1	41.4 percentage of participants Interval 28.6 to 55.1	50.8 percentage of participants Interval 37.5 to 64.1
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	33.3 percentage of participants Interval 20.4 to 48.4	69.2 percentage of participants Interval 54.9 to 81.3	36.2 percentage of participants Interval 24.0 to 49.9	91.5 percentage of participants Interval 81.3 to 97.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	35.4 percentage of participants Interval 22.2 to 50.5	86.5 percentage of participants Interval 74.2 to 94.4	43.1 percentage of participants Interval 30.2 to 56.8	96.6 percentage of participants Interval 88.3 to 99.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	31.9 percentage of participants Interval 19.1 to 47.1	70.0 percentage of participants Interval 55.4 to 82.1	47.4 percentage of participants Interval 34.0 to 61.0	86.4 percentage of participants Interval 75.0 to 94.0
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	32.6 percentage of participants Interval 19.5 to 48.0	62.0 percentage of participants Interval 47.2 to 75.3	43.6 percentage of participants Interval 30.3 to 57.7	82.8 percentage of participants Interval 70.6 to 91.4
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	27.3 percentage of participants Interval 15.0 to 42.8	42.9 percentage of participants Interval 28.8 to 57.8	35.2 percentage of participants Interval 22.7 to 49.4	55.2 percentage of participants Interval 41.5 to 68.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	31.7 percentage of participants Interval 18.1 to 48.1	31.1 percentage of participants Interval 18.2 to 46.6	29.4 percentage of participants Interval 17.5 to 43.8	58.2 percentage of participants Interval 44.1 to 71.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	29.3 percentage of participants Interval 16.1 to 45.5	27.3 percentage of participants Interval 15.0 to 42.8	26.0 percentage of participants Interval 14.6 to 40.3	52.8 percentage of participants Interval 38.6 to 66.7

SECONDARY outcome

Timeframe: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=48 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=52 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=58 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=59 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	25.0 percentage of participants Interval 13.6 to 39.6	69.2 percentage of participants Interval 54.9 to 81.3	25.9 percentage of participants Interval 15.3 to 39.0	89.8 percentage of participants Interval 79.2 to 96.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 1	29.2 percentage of participants Interval 17.0 to 44.1	9.6 percentage of participants Interval 3.2 to 21.0	27.6 percentage of participants Interval 16.7 to 40.9	40.7 percentage of participants Interval 28.1 to 54.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	25.0 percentage of participants Interval 13.6 to 39.6	86.5 percentage of participants Interval 74.2 to 94.4	29.3 percentage of participants Interval 18.1 to 42.7	96.6 percentage of participants Interval 88.3 to 99.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	19.1 percentage of participants Interval 9.1 to 33.3	70.0 percentage of participants Interval 55.4 to 82.1	29.8 percentage of participants Interval 18.4 to 43.4	84.7 percentage of participants Interval 73.0 to 92.8
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	17.4 percentage of participants Interval 7.8 to 31.4	62.0 percentage of participants Interval 47.2 to 75.3	25.5 percentage of participants Interval 14.7 to 39.0	81.0 percentage of participants Interval 68.6 to 90.1
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	9.1 percentage of participants Interval 2.5 to 21.7	40.8 percentage of participants Interval 27.0 to 55.8	14.8 percentage of participants Interval 6.6 to 27.1	53.4 percentage of participants Interval 39.9 to 66.7
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	22.7 percentage of participants Interval 11.5 to 37.8	29.2 percentage of participants Interval 17.0 to 44.1	26.4 percentage of participants Interval 15.3 to 40.3	50.9 percentage of participants Interval 37.3 to 64.4
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	12.2 percentage of participants Interval 4.1 to 26.2	22.2 percentage of participants Interval 11.2 to 37.1	15.7 percentage of participants Interval 7.0 to 28.6	47.3 percentage of participants Interval 33.7 to 61.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	9.8 percentage of participants Interval 2.7 to 23.1	18.2 percentage of participants Interval 8.2 to 32.7	8.0 percentage of participants Interval 2.2 to 19.2	45.3 percentage of participants Interval 31.6 to 59.6

SECONDARY outcome

Timeframe: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=16 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=18 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=24 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=20 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 1	88 neutralization units per milliliter Interval 70.1 to 110.1	142 neutralization units per milliliter Interval 90.7 to 221.6	120 neutralization units per milliliter Interval 90.9 to 159.2	198 neutralization units per milliliter Interval 111.4 to 351.8
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	88 neutralization units per milliliter Interval 74.9 to 103.6	2161 neutralization units per milliliter Interval 1199.3 to 3895.6	118 neutralization units per milliliter Interval 92.1 to 149.9	3787 neutralization units per milliliter Interval 1885.2 to 7608.4
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	95 neutralization units per milliliter Interval 70.4 to 128.3	5446 neutralization units per milliliter Interval 3389.1 to 8751.2	126 neutralization units per milliliter Interval 95.3 to 165.5	8013 neutralization units per milliliter Interval 5104.5 to 12578.9
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	85 neutralization units per milliliter Interval 72.9 to 98.5	447 neutralization units per milliliter Interval 276.9 to 722.8	95 neutralization units per milliliter Interval 79.5 to 113.0	659 neutralization units per milliliter Interval 399.6 to 1087.2
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	89 neutralization units per milliliter Interval 69.0 to 114.9	1745 neutralization units per milliliter Interval 1061.2 to 2870.5	109 neutralization units per milliliter Interval 84.7 to 140.3	2686 neutralization units per milliliter Interval 1640.9 to 4397.2
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	87 neutralization units per milliliter Interval 70.4 to 108.6	908 neutralization units per milliliter Interval 602.7 to 1367.0	96 neutralization units per milliliter Interval 76.6 to 120.6	1417 neutralization units per milliliter Interval 892.5 to 2249.6
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	96 neutralization units per milliliter Interval 71.7 to 128.3	666 neutralization units per milliliter Interval 393.0 to 1129.3	102 neutralization units per milliliter Interval 78.7 to 131.8	925 neutralization units per milliliter Interval 623.8 to 1372.1
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	87 neutralization units per milliliter Interval 70.9 to 106.1	468 neutralization units per milliliter Interval 291.8 to 749.7	92 neutralization units per milliliter Interval 77.1 to 110.1	656 neutralization units per milliliter Interval 448.0 to 961.7
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	89 neutralization units per milliliter Interval 68.2 to 117.5	495 neutralization units per milliliter Interval 294.3 to 832.1	96 neutralization units per milliliter Interval 79.3 to 116.0	774 neutralization units per milliliter Interval 492.1 to 1216.6

SECONDARY outcome

Timeframe: Extension Stage Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=16 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=18 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=24 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=20 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	216 neutralization units per milliliter Interval 127.4 to 365.6	5428 neutralization units per milliliter Interval 3375.7 to 8728.5	941 neutralization units per milliliter Interval 342.2 to 2587.5	8340 neutralization units per milliliter Interval 3977.0 to 17489.0
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 1	267 neutralization units per milliliter Interval 135.4 to 524.8	1352 neutralization units per milliliter Interval 637.0 to 2871.7	791 neutralization units per milliliter Interval 348.6 to 1792.5	1632 neutralization units per milliliter Interval 626.0 to 4256.6
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	256 neutralization units per milliliter Interval 135.7 to 482.0	14754 neutralization units per milliliter Interval 6929.5 to 31414.7	807 neutralization units per milliliter Interval 331.2 to 1968.2	18832 neutralization units per milliliter Interval 8516.0 to 41644.3
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	289 neutralization units per milliliter Interval 149.7 to 559.0	25297 neutralization units per milliliter Interval 15053.2 to 42513.1	939 neutralization units per milliliter Interval 406.4 to 2169.6	50637 neutralization units per milliliter Interval 26616.8 to 96335.4
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	322 neutralization units per milliliter Interval 169.2 to 613.1	12467 neutralization units per milliliter Interval 7673.0 to 20257.7	876 neutralization units per milliliter Interval 356.0 to 2154.5	19239 neutralization units per milliliter Interval 9155.7 to 40426.7
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	298 neutralization units per milliliter Interval 162.3 to 545.2	6707 neutralization units per milliliter Interval 4294.7 to 10475.5	787 neutralization units per milliliter Interval 308.1 to 2009.2	11126 neutralization units per milliliter Interval 5350.8 to 23136.3
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	211 neutralization units per milliliter Interval 125.1 to 355.6	3530 neutralization units per milliliter Interval 2312.5 to 5387.9	932 neutralization units per milliliter Interval 360.3 to 2408.7	7101 neutralization units per milliliter Interval 3501.0 to 14403.0
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	221 neutralization units per milliliter Interval 122.6 to 399.0	3373 neutralization units per milliliter Interval 2150.1 to 5290.8	709 neutralization units per milliliter Interval 273.2 to 1841.3	6061 neutralization units per milliliter Interval 3387.3 to 10846.4
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	239 neutralization units per milliliter Interval 113.2 to 505.4	3457 neutralization units per milliliter Interval 2137.7 to 5590.4	689 neutralization units per milliliter Interval 280.2 to 1694.7	7115 neutralization units per milliliter Interval 3694.4 to 13701.5

SECONDARY outcome

Timeframe: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=48 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=52 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=58 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=59 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 1	230 neutralization units per milliliter Interval 173.7 to 304.7	152 neutralization units per milliliter Interval 120.7 to 192.4	249 neutralization units per milliliter Interval 185.3 to 334.0	281 neutralization units per milliliter Interval 212.4 to 372.9
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	173 neutralization units per milliliter Interval 130.9 to 229.8	298 neutralization units per milliliter Interval 227.3 to 391.5	193 neutralization units per milliliter Interval 147.3 to 254.1	438 neutralization units per milliliter Interval 337.6 to 569.2
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	235 neutralization units per milliliter Interval 182.2 to 303.6	1188 neutralization units per milliliter Interval 880.5 to 1603.8	271 neutralization units per milliliter Interval 202.0 to 362.6	2300 neutralization units per milliliter Interval 1709.2 to 3095.2
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	200 neutralization units per milliliter Interval 151.8 to 264.0	3288 neutralization units per milliliter Interval 2464.9 to 4384.7	283 neutralization units per milliliter Interval 211.8 to 376.9	4695 neutralization units per milliliter Interval 3469.1 to 6352.8
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	172 neutralization units per milliliter Interval 129.3 to 227.7	1107 neutralization units per milliliter Interval 864.9 to 1415.8	227 neutralization units per milliliter Interval 167.3 to 307.0	1538 neutralization units per milliliter Interval 1195.0 to 1980.3
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	163 neutralization units per milliliter Interval 118.8 to 223.2	649 neutralization units per milliliter Interval 502.8 to 838.5	211 neutralization units per milliliter Interval 159.6 to 280.2	982 neutralization units per milliliter Interval 802.8 to 1201.6
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	130 neutralization units per milliliter Interval 99.5 to 170.9	348 neutralization units per milliliter Interval 266.1 to 456.2	139 neutralization units per milliliter Interval 107.7 to 180.4	497 neutralization units per milliliter Interval 395.3 to 624.8
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	120 neutralization units per milliliter Interval 94.2 to 153.5	273 neutralization units per milliliter Interval 216.3 to 343.5	146 neutralization units per milliliter Interval 115.0 to 185.5	386 neutralization units per milliliter Interval 295.3 to 505.3
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	129 neutralization units per milliliter Interval 99.1 to 168.5	222 neutralization units per milliliter Interval 174.0 to 284.0	141 neutralization units per milliliter Interval 111.2 to 179.5	355 neutralization units per milliliter Interval 276.6 to 455.8

SECONDARY outcome

Timeframe: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=48 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=52 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=58 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=59 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	1347 neutralization units per milliliter Interval 823.7 to 2201.9	5011 neutralization units per milliliter Interval 3346.2 to 7504.7	1862 neutralization units per milliliter Interval 1179.8 to 2938.7	17205 neutralization units per milliliter Interval 12065.9 to 24534.4
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 1	1424 neutralization units per milliliter Interval 891.9 to 2273.8	704 neutralization units per milliliter Interval 480.8 to 1031.1	1925 neutralization units per milliliter Interval 1220.4 to 3037.8	2186 neutralization units per milliliter Interval 1483.4 to 3220.4
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	1328 neutralization units per milliliter Interval 819.3 to 2151.5	11885 neutralization units per milliliter Interval 7950.3 to 17768.1	1776 neutralization units per milliliter Interval 1185.2 to 2661.8	32905 neutralization units per milliliter Interval 23885.1 to 45330.7
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	1258 neutralization units per milliliter Interval 789.4 to 2004.7	4306 neutralization units per milliliter Interval 2991.0 to 6200.4	2056 neutralization units per milliliter Interval 1315.2 to 3212.9	10842 neutralization units per milliliter Interval 7872.3 to 14930.8
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	1207 neutralization units per milliliter Interval 735.7 to 1979.2	2693 neutralization units per milliliter Interval 1856.1 to 3906.0	1681 neutralization units per milliliter Interval 1102.4 to 2563.7	7126 neutralization units per milliliter Interval 5159.1 to 9843.7
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	875 neutralization units per milliliter Interval 550.5 to 1389.7	1587 neutralization units per milliliter Interval 1033.5 to 2437.7	997 neutralization units per milliliter Interval 639.4 to 1555.0	3079 neutralization units per milliliter Interval 2254.0 to 4205.8
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	1613 neutralization units per milliliter Interval 983.7 to 2643.9	1464 neutralization units per milliliter Interval 925.8 to 2313.9	1436 neutralization units per milliliter Interval 900.1 to 2289.6	3299 neutralization units per milliliter Interval 2323.1 to 4684.7
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	911 neutralization units per milliliter Interval 548.4 to 1513.6	1400 neutralization units per milliliter Interval 945.9 to 2072.9	1227 neutralization units per milliliter Interval 831.6 to 1809.0	3027 neutralization units per milliliter Interval 2179.6 to 4204.5
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	885 neutralization units per milliliter Interval 523.8 to 1494.8	1165 neutralization units per milliliter Interval 751.0 to 1808.4	1021 neutralization units per milliliter Interval 689.4 to 1511.1	2408 neutralization units per milliliter Interval 1785.1 to 3247.1

SECONDARY outcome

Timeframe: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=16 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=18 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=24 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=20 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	1.00 fold rise Interval 0.99 to 1.0	6.40 fold rise Interval 3.55 to 11.55	0.90 fold rise Interval 0.71 to 1.15	7.16 fold rise Interval 3.95 to 12.98
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	1.09 fold rise Interval 0.84 to 1.42	4.54 fold rise Interval 2.47 to 8.33	0.94 fold rise Interval 0.73 to 1.22	4.67 fold rise Interval 2.61 to 8.37
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	1.00 fold rise Interval 0.88 to 1.15	15.25 fold rise Interval 8.57 to 27.11	0.98 fold rise Interval 0.84 to 1.14	19.13 fold rise Interval 9.09 to 40.28
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	1.08 fold rise Interval 0.96 to 1.22	38.41 fold rise Interval 21.07 to 70.02	1.04 fold rise Interval 0.87 to 1.26	40.47 fold rise Interval 18.52 to 88.48
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	1.01 fold rise Interval 0.98 to 1.04	12.31 fold rise Interval 6.45 to 23.51	0.95 fold rise Interval 0.77 to 1.17	13.57 fold rise Interval 7.33 to 25.1
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	0.97 fold rise Interval 0.73 to 1.28	3.05 fold rise Interval 1.81 to 5.14	0.88 fold rise Interval 0.68 to 1.14	3.29 fold rise Interval 1.71 to 6.34
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	0.97 fold rise Interval 0.92 to 1.03	3.19 fold rise Interval 1.89 to 5.39	0.85 fold rise Interval 0.67 to 1.09	3.32 fold rise Interval 1.94 to 5.67
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	0.99 fold rise Interval 0.98 to 1.01	3.74 fold rise Interval 2.32 to 6.03	0.89 fold rise Interval 0.72 to 1.1	3.91 fold rise Interval 2.09 to 7.33

SECONDARY outcome

Timeframe: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=16 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=18 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=24 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=20 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	0.96 fold rise Interval 0.78 to 1.18	10.91 fold rise Interval 6.02 to 19.75	1.02 fold rise Interval 0.84 to 1.25	11.54 fold rise Interval 5.7 to 23.34
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	1.09 fold rise Interval 0.9 to 1.3	18.70 fold rise Interval 9.46 to 36.99	1.19 fold rise Interval 1.03 to 1.36	31.02 fold rise Interval 13.73 to 70.07
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	1.21 fold rise Interval 0.94 to 1.55	9.22 fold rise Interval 4.62 to 18.39	1.09 fold rise Interval 0.9 to 1.31	11.79 fold rise Interval 5.68 to 24.44
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	1.12 fold rise Interval 0.79 to 1.58	4.96 fold rise Interval 2.76 to 8.91	0.93 fold rise Interval 0.76 to 1.15	6.82 fold rise Interval 3.39 to 13.69
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	0.81 fold rise Interval 0.58 to 1.13	3.49 fold rise Interval 1.96 to 6.22	1.02 fold rise Interval 0.75 to 1.38	5.11 fold rise Interval 2.28 to 11.44
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	0.79 fold rise Interval 0.5 to 1.26	2.27 fold rise Interval 1.26 to 4.09	1.01 fold rise Interval 0.72 to 1.41	3.80 fold rise Interval 1.88 to 7.66
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	0.74 fold rise Interval 0.5 to 1.11	2.17 fold rise Interval 1.3 to 3.61	0.77 fold rise Interval 0.58 to 1.0	3.13 fold rise Interval 1.41 to 6.96
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	0.87 fold rise Interval 0.65 to 1.16	2.40 fold rise Interval 1.52 to 3.79	0.74 fold rise Interval 0.57 to 0.98	3.68 fold rise Interval 1.78 to 7.59

SECONDARY outcome

Timeframe: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=48 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=52 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=58 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=59 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	0.76 fold rise Interval 0.56 to 1.04	1.89 fold rise Interval 1.4 to 2.55	0.75 fold rise Interval 0.57 to 1.0	1.55 fold rise Interval 1.17 to 2.03
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	0.57 fold rise Interval 0.46 to 0.72	2.24 fold rise Interval 1.65 to 3.04	0.55 fold rise Interval 0.46 to 0.65	1.73 fold rise Interval 1.36 to 2.2
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	0.71 fold rise Interval 0.6 to 0.83	4.15 fold rise Interval 3.1 to 5.55	0.85 fold rise Interval 0.74 to 0.98	3.41 fold rise Interval 2.69 to 4.34
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	1.02 fold rise Interval 0.9 to 1.16	7.80 fold rise Interval 5.74 to 10.59	1.09 fold rise Interval 0.97 to 1.22	8.17 fold rise Interval 5.97 to 11.19
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	0.87 fold rise Interval 0.76 to 1.0	21.57 fold rise Interval 16.24 to 28.65	1.14 fold rise Interval 1.01 to 1.28	16.68 fold rise Interval 11.72 to 23.74
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	0.74 fold rise Interval 0.67 to 0.83	7.07 fold rise Interval 5.22 to 9.58	0.89 fold rise Interval 0.76 to 1.05	5.47 fold rise Interval 4.19 to 7.13
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	0.51 fold rise Interval 0.42 to 0.62	1.76 fold rise Interval 1.33 to 2.34	0.56 fold rise Interval 0.47 to 0.67	1.34 fold rise Interval 1.03 to 1.74
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	0.55 fold rise Interval 0.43 to 0.7	1.45 fold rise Interval 1.03 to 2.03	0.53 fold rise Interval 0.43 to 0.66	1.22 fold rise Interval 0.91 to 1.64

SECONDARY outcome

Timeframe: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=48 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=52 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=58 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=59 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36	0.56 fold rise Interval 0.35 to 0.89	1.85 fold rise Interval 1.23 to 2.78	0.47 fold rise Interval 0.37 to 0.61	1.09 fold rise Interval 0.82 to 1.44
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18	0.58 fold rise Interval 0.42 to 0.79	2.25 fold rise Interval 1.49 to 3.38	0.51 fold rise Interval 0.4 to 0.65	1.34 fold rise Interval 1.06 to 1.7
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24	1.07 fold rise Interval 0.61 to 1.86	2.00 fold rise Interval 1.19 to 3.34	0.70 fold rise Interval 0.5 to 0.98	1.45 fold rise Interval 1.09 to 1.93
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30	0.58 fold rise Interval 0.41 to 0.8	2.09 fold rise Interval 1.4 to 3.13	0.60 fold rise Interval 0.47 to 0.77	1.36 fold rise Interval 1.0 to 1.84
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8	0.95 fold rise Interval 0.82 to 1.09	7.12 fold rise Interval 4.98 to 10.16	0.97 fold rise Interval 0.88 to 1.07	7.87 fold rise Interval 5.6 to 11.06
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30	0.93 fold rise Interval 0.81 to 1.07	16.88 fold rise Interval 11.25 to 25.33	0.92 fold rise Interval 0.79 to 1.07	15.05 fold rise Interval 10.49 to 21.6
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6	0.86 fold rise Interval 0.77 to 0.95	5.97 fold rise Interval 4.22 to 8.45	1.08 fold rise Interval 0.86 to 1.36	4.96 fold rise Interval 3.79 to 6.49
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12	0.81 fold rise Interval 0.69 to 0.95	3.73 fold rise Interval 2.69 to 5.17	0.89 fold rise Interval 0.71 to 1.11	3.10 fold rise Interval 2.47 to 3.89

SECONDARY outcome

Timeframe: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Toxin A antibodies were measured using neutralization assay.

Outcome measures

SECONDARY outcome

Timeframe: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Toxin B antibodies were measured using neutralization assay.

Outcome measures

SECONDARY outcome

Timeframe: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Toxin A and B antibodies were measured using neutralization assay.

Outcome measures

SECONDARY outcome

Timeframe: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Toxin A antibodies were measured using neutralization assay.

Outcome measures

SECONDARY outcome

Timeframe: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Toxin B antibodies were measured using neutralization assay.

Outcome measures

SECONDARY outcome

Timeframe: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4

Toxin A and B antibodies were measured using neutralization assay.

Outcome measures

SECONDARY outcome

Timeframe: Within 14 days after Vaccination 4

Population: Safety population: all participants who received at least 1 dose of the investigational product.

Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (grade 1) (did not interfere with activity), moderate (grade 2) (interfered with activity), severe (grade 3) (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). Any local reaction referred to any injection site pain, any swelling, or any redness.

Outcome measures

SECONDARY outcome

Timeframe: Within 14 days after Vaccination 4

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

Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (grade 1) (did not interfere with activity), moderate (grade 2) (interfered with activity), severe (grade 3) (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). Any local reaction referred to any injection site pain, any swelling, or any redness.

Outcome measures

SECONDARY outcome

Timeframe: Within 14 days after Vaccination 4

Population: Safety population: all participants who received at least 1 dose of the investigational product.

Systemic events included following events: Fever was graded as mild (38.0 to 38.4 degree C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade (G) 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration)/grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and G4 (hospitalization). Headache, fatigue, new/worsening muscle pain and new/worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and G4 (hospitalization). Any systemic event referred to any fever \>= 38.0 degree C, any vomiting, any diarrhea, any headache, any fatigue, any new/worsening muscle pain, or any new or worsening joint pain.

Outcome measures

SECONDARY outcome

Timeframe: within 14 days after Vaccination 4

Outcome measures

SECONDARY outcome

Timeframe: From Vaccination 4 up to 28 days after Vaccination 4

Population: Safety population: all participants who received at least 1 dose of the investigational product.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent adverse events are events from dose 4 of study drug to 28 days after dose 4 of study drug that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=16 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=18 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=24 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=22 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs)	1 Participants	0 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: From Vaccination 4 up to 28 days after Vaccination 4

Population: Safety population: all participants who received at least 1 dose of the investigational product.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=51 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=52 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=58 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=59 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs)	10 Participants	8 Participants	17 Participants	16 Participants

SECONDARY outcome

Timeframe: From Vaccination 4 up to 6 months after Vaccination 4

Population: Safety population: all participants who received at least 1 dose of the investigational product.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events from dose 4 of study drug to 6 months after dose 4 of study drug that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=16 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=18 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=24 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=22 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From Vaccination 4 up to 6 months after Vaccination 4

Population: Safety population: all participants who received at least 1 dose of the investigational product.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events from dose 4 of study drug to 6 months after dose 4 of study drug that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Placebo: Day 1, 8 and 30 Regimen n=51 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=52 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=58 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=59 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)	2 Participants	1 Participants	1 Participants	3 Participants

Adverse Events

Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen

Serious events: 11 serious events

Other events: 128 other events

Deaths: 2 deaths

Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen

Serious events: 6 serious events

Other events: 144 other events

Deaths: 1 deaths

Placebo: Day 1, 8 and 30 Regimen

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Clostridium Difficile Vaccine(100 mcg): Month 0, 1 and 6 Regimen

Serious events: 19 serious events

Other events: 158 other events

Deaths: 2 deaths

Clostridium Difficile Vaccine(200 mcg): Month 0, 1 and 6 Regimen

Serious events: 22 serious events

Other events: 156 other events

Deaths: 0 deaths

Placebo: Month 0, 1 and 6 Regimen

Serious events: 2 serious events

Other events: 52 other events

Deaths: 0 deaths

100mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen

Serious events: 6 serious events

Other events: 9 other events

Deaths: 0 deaths

100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

200mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen

Serious events: 2 serious events

Other events: 14 other events

Deaths: 1 deaths

100mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

200mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen

Serious events: 6 serious events

Other events: 31 other events

Deaths: 0 deaths

200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen

Serious events: 5 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=182 participants at risk Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=184 participants at risk Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Placebo: Day 1, 8 and 30 Regimen n=61 participants at risk Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg): Month 0, 1 and 6 Regimen n=183 participants at risk Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.	Clostridium Difficile Vaccine(200 mcg): Month 0, 1 and 6 Regimen n=183 participants at risk Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.	Placebo: Month 0, 1 and 6 Regimen n=61 participants at risk Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen n=16 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=18 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received a fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen n=24 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=22 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen n=51 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen n=52 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen n=58 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen n=59 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Cardiac disorders Atrioventricular block complete	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Cardiac arrest	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Clostridium difficile colitis	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage II	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	5.6% 1/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Cerebrovascular accident	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Hydrocephalus	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Ischaemic stroke	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Metabolic encephalopathy	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Myelopathy	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Product Issues Device malfunction	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Acute myocardial infarction	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Angina unstable	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Arrhythmia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Atrial fibrillation	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Coronary artery disease	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Coronary artery occlusion	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Mitral valve incompetence	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Myocardial infarction	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Supraventricular tachycardia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Hepatobiliary disorders Cholecystitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Cellulitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Diverticulitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Kidney infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Meningoencephalitis viral	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Pneumonia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Sepsis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Urinary tract infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Chemical burn	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Face injury	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Fall	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.5% 1/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Overdose	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	12.5% 2/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	5.6% 1/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Amyotrophic lateral sclerosis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Carotid artery disease	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Presyncope	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Seizure	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Syncope	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Obstructive uropathy	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Urinary retention	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Deep vein thrombosis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Hypertension	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Hypotension	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Cardiovascular disorder	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.5% 1/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Sinus arrest	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	5.6% 1/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Pericarditis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Gastroenteritis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.2% 1/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.2% 1/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.2% 1/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.5% 1/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.2% 1/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Hemiplegia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Aortic aneurysm	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.2% 1/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Pyelonephritis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Staphylococcal osteomyelitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Traumatic arthrosis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell type acute leukaemia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Hypoglycaemic encephalopathy	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Sciatica	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Thrombosis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.

Other adverse events

Other adverse events
Measure	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=182 participants at risk Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=184 participants at risk Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Placebo: Day 1, 8 and 30 Regimen n=61 participants at risk Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg): Month 0, 1 and 6 Regimen n=183 participants at risk Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.	Clostridium Difficile Vaccine(200 mcg): Month 0, 1 and 6 Regimen n=183 participants at risk Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.	Placebo: Month 0, 1 and 6 Regimen n=61 participants at risk Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen n=16 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=18 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received a fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen n=24 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=22 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen n=51 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen n=52 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen n=58 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen n=59 participants at risk Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Cardiac disorders Atrial fibrillation	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Bradycardia	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Coronary artery occlusion	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Endocrine disorders Hyperthyroidism	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Eye haemorrhage	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Retinoschisis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Abdominal pain lower	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Anal incontinence	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Anorectal disorder	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Diarrhoea	2.2% 4/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.3% 2/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.7% 5/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.2% 4/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.9% 2/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Nausea	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.2% 4/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.5% 1/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Toothache	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Vomiting	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.7% 5/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.3% 2/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.7% 5/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.2% 4/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.3% 2/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	5.6% 1/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.5% 1/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.4% 2/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Chest discomfort	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Chest pain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Chills	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Fatigue	23.6% 43/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	32.1% 59/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	32.8% 20/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	44.3% 81/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	37.7% 69/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	39.3% 24/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	37.5% 6/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	27.8% 5/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	8.3% 2/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	18.2% 4/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	17.6% 9/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	15.4% 8/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	24.1% 14/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	20.3% 12/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Influenza like illness	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site bruising	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site erythema	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site haematoma	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site haemorrhage	4.9% 9/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.9% 9/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site macule	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site pain	2.2% 4/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site pruritus	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.5% 1/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site rash	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site swelling	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site warmth	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Oedema peripheral	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.7% 5/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	5.2% 3/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Pain	1.1% 2/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Tenderness	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Vessel puncture site swelling	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Immune system disorders Multiple allergies	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Bronchitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.3% 2/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Eye infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Folliculitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Herpes zoster	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Incision site infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Nasopharyngitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.9% 4/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Sinusitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.3% 2/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.3% 6/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Tooth infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Upper respiratory tract infection	2.2% 4/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.3% 8/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.3% 2/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	8.7% 16/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	9.3% 17/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	8.2% 5/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.9% 2/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.4% 2/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.4% 2/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Urinary tract infection	1.6% 3/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.7% 5/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	8.2% 5/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Viral upper respiratory tract infection	1.1% 2/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.4% 8/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.2% 4/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.3% 2/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.2% 1/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Root canal infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Labyrinthitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Arthropod sting	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Burns first degree	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Contusion	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Excoriation	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Face injury	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Fall	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.2% 4/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Joint injury	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Muscle strain	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Road traffic accident	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Tendon rupture	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Thermal burn	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Gout	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Hypovolaemia	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.7% 5/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 3/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.9% 9/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.4% 2/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.3% 6/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.9% 9/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.4% 2/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.2% 4/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Osteoporosis postmenopausal	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 2/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.7% 5/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.3% 6/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Spinal pain	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Dizziness	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.2% 4/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Headache	19.2% 35/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	25.0% 46/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	26.2% 16/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	28.4% 52/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	30.6% 56/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	37.7% 23/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.2% 1/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	5.6% 1/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	16.7% 4/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	9.1% 2/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	11.8% 6/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	9.6% 5/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	10.3% 6/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.4% 2/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Transient ischaemic attack	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Psychiatric disorders Adjustment disorder with mixed anxiety and depressed mood	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Psychiatric disorders Anxiety	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Psychiatric disorders Insomnia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Psychiatric disorders Stress	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Haematuria	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Incontinence	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Nephrolithiasis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Reproductive system and breast disorders Breast calcifications	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Reproductive system and breast disorders Fibrocystic breast disease	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Emphysema	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.1% 2/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Dermatitis contact	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Ecchymosis	0.55% 1/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Rash	1.1% 2/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Varicose vein	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Angina pectoris	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Aortic valve incompetence	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Arrhythmia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Cardiac failure congestive	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Cardiomegaly	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Coronary artery disease	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Extrasystoles	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Mitral valve calcification	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Mitral valve incompetence	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Palpitations	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Pericardial effusion	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Right atrial dilatation	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Right ventricular dilatation	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Sinus node dysfunction	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Sinus tachycardia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Tachycardia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Ventricular extrasystoles	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Cardiac disorders Ventricular tachycardia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Congenital, familial and genetic disorders Factor V deficiency	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Ear and labyrinth disorders Ear pain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Ear and labyrinth disorders Meniere's disease	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Ear and labyrinth disorders Tinnitus	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Ear and labyrinth disorders Vertigo positional	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Endocrine disorders Hypogonadism	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Dry eye	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Eye disorder	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Eye swelling	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Glaucoma	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Lacrimation increased	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Neovascular age-related macular degeneration	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Retinal vein occlusion	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Vision blurred	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Vitreous floaters	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Abdominal distension	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Abdominal mass	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Anal fissure	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Change of bowel habit	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Cheilitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Constipation	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.2% 1/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Dental caries	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Eructation	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Food poisoning	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Gastritis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Haemorrhoids	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Hiatus hernia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Tooth disorder	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Drug intolerance	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Facial pain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site discolouration	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site erosion	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site nodule	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Pyrexia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Hepatobiliary disorders Cholelithiasis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Hepatobiliary disorders Hepatic cyst	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Hepatobiliary disorders Hepatitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Hepatobiliary disorders Hepatomegaly	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Immune system disorders Food allergy	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Immune system disorders Seasonal allergy	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Acute sinusitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Body tinea	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Cellulitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Clostridium difficile infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Conjunctivitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Cystitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Diverticulitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Ear infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Fungal infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Furuncle	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Gastroenteritis viral	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Gastroenteritis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.9% 3/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Gingivitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Hordeolum	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Infected bite	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Infected dermal cyst	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Influenza	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Laryngitis viral	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Lip infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Localised infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Meningitis viral	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Onychomycosis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Oral herpes	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Periodontitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Pharyngitis streptococcal	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Pharyngitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Pneumonia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.2% 4/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Tinea pedis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Tooth abscess	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Varicella zoster virus infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Viral infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Animal bite	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Concussion	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Head injury	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Laceration	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Lenticular injury	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Vitreous injury	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Investigations Blood cholesterol increased	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Investigations Blood pressure increased	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.2% 4/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Investigations Brain natriuretic peptide increased	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Investigations Cardiac murmur	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.3% 2/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Investigations Fibrin D dimer increased	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Investigations Ophthalmological examination abnormal	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Investigations Prostatic specific antigen increased	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Investigations Red reflex abnormal	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Dehydration	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Food intolerance	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Bone cyst	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.8% 7/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac neoplasm unspecified	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinaemia benign monoclonal	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Psychiatric disorders Depressed mood	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Hypoaesthesia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Lumbar radiculopathy	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Migraine	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Neuralgia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Neuropathy peripheral	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Sciatica	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.2% 4/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Syncope	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Psychiatric disorders Depression	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Psychiatric disorders Panic attack	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Acute kidney injury	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Cystitis noninfective	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Dysuria	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Hypertonic bladder	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Nocturia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Pollakiuria	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Renal cyst	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Renal failure	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Renal impairment	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Renal and urinary disorders Urinary retention	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.5% 1/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Paranasal cyst	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Blister	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Papule	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Precancerous skin lesion	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Aortic arteriosclerosis	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Aortic dilatation	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Hypertension	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.8% 7/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.4% 2/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Hypotension	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Vascular disorders Peripheral venous disease	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal neoplasm	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Nervous system disorders Disturbance in attention	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Reproductive system and breast disorders Breast cyst	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.54% 1/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Endocrine disorders Hypothyroidism	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Abdominal pain	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 3/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Vessel puncture site haemorrhage	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.55% 1/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.9% 2/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Pyrexia (fever)	1.1% 2/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.2% 4/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.7% 5/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.1% 2/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site erythema (redness)	5.5% 10/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	11.4% 21/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.0% 11/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.0% 11/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.6% 1/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	13.6% 3/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.4% 2/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site pain (pain)	42.3% 77/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	50.0% 92/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	9.8% 6/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	42.1% 77/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	45.4% 83/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	14.8% 9/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.2% 1/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	5.6% 1/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	27.3% 6/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	5.9% 3/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	23.1% 12/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.4% 2/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	20.3% 12/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Injection site swelling (swelling)	6.0% 11/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	10.3% 19/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	5.5% 10/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	8.7% 16/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	13.6% 3/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.4% 2/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Diarrhoea (diarrhea)	14.3% 26/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	20.1% 37/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	26.2% 16/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	35.5% 65/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	32.2% 59/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	27.9% 17/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	12.5% 2/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	16.7% 3/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	25.0% 6/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	13.6% 3/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	15.7% 8/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	13.5% 7/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	13.8% 8/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	11.9% 7/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Arthralgia (joint pain)	8.2% 15/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	16.8% 31/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	9.8% 6/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	19.1% 35/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	24.6% 45/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	14.8% 9/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	12.5% 2/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	5.6% 1/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.5% 1/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	7.8% 4/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	3.8% 2/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	12.1% 7/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.8% 4/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Musculoskeletal and connective tissue disorders Myalgia (muscle pain)	15.9% 29/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	22.3% 41/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	13.1% 8/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	25.7% 47/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	23.0% 42/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	18.0% 11/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.2% 1/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	22.7% 5/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	5.9% 3/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	7.7% 4/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	17.2% 10/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	6.8% 4/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
General disorders Vessel puncture site erythema	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.2% 1/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	4.5% 1/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Eye disorders Macular cyst	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Immune system disorders Allergy to animal	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Infections and infestations Staphylococcal infection	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.7% 1/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	1.9% 1/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.
Investigations Blood folate decreased	0.00% 0/182 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/184 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/183 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/61 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/16 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/18 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/24 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/22 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	2.0% 1/51 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/52 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/58 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.	0.00% 0/59 • AEs: From Vaccination 1 up to 1 month after Vaccination 3 (up to Month 2 for day regimen and Month 7 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs: From Vaccination 1 through 6 months after Vaccination 3 (Month 7 for day regimen and Month 12 for month regimen); from Vaccination 4 up to 36 months (after Vaccination 4) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). Safety population: all participants who received at least 1 dose of the investigational product.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo: Day 1, 8 and 30 Regimen n=61 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=182 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=182 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Pain: Moderate	1.6 percentage of participants Interval 0.0 to 8.8	2.2 percentage of participants Interval 0.6 to 5.5	0.0 percentage of participants Interval 0.0 to 2.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Pain: Severe	0.0 percentage of participants Interval 0.0 to 5.9	0.0 percentage of participants Interval 0.0 to 2.0	0.5 percentage of participants Interval 0.0 to 3.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Pain: Any	8.2 percentage of participants Interval 2.7 to 18.1	24.2 percentage of participants Interval 18.1 to 31.1	19.8 percentage of participants Interval 14.3 to 26.3	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Pain: Mild	6.6 percentage of participants Interval 1.8 to 15.9	22.0 percentage of participants Interval 16.2 to 28.7	19.2 percentage of participants Interval 13.8 to 25.7	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Pain: Grade 4	0.0 percentage of participants Interval 0.0 to 5.9	0.0 percentage of participants Interval 0.0 to 2.0	0.0 percentage of participants Interval 0.0 to 2.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Redness: Any	1.6 percentage of participants Interval 0.0 to 8.8	1.1 percentage of participants Interval 0.1 to 3.9	2.2 percentage of participants Interval 0.6 to 5.5	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Redness: Mild	1.6 percentage of participants Interval 0.0 to 8.8	0.0 percentage of participants Interval 0.0 to 2.0	1.1 percentage of participants Interval 0.1 to 3.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Redness: Moderate	0.0 percentage of participants Interval 0.0 to 5.9	1.1 percentage of participants Interval 0.1 to 3.9	0.5 percentage of participants Interval 0.0 to 3.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Redness: Severe	0.0 percentage of participants Interval 0.0 to 5.9	0.0 percentage of participants Interval 0.0 to 2.0	0.5 percentage of participants Interval 0.0 to 3.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Redness: Grade 4	0.0 percentage of participants Interval 0.0 to 5.9	0.0 percentage of participants Interval 0.0 to 2.0	0.0 percentage of participants Interval 0.0 to 2.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Swelling: Any	0.0 percentage of participants Interval 0.0 to 5.9	1.1 percentage of participants Interval 0.1 to 3.9	1.1 percentage of participants Interval 0.1 to 3.9	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Swelling: Mild	0.0 percentage of participants Interval 0.0 to 5.9	0.5 percentage of participants Interval 0.0 to 3.0	0.0 percentage of participants Interval 0.0 to 2.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Swelling: Moderate	0.0 percentage of participants Interval 0.0 to 5.9	0.5 percentage of participants Interval 0.0 to 3.0	0.5 percentage of participants Interval 0.0 to 3.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Swelling: Severe	0.0 percentage of participants Interval 0.0 to 5.9	0.0 percentage of participants Interval 0.0 to 2.0	0.5 percentage of participants Interval 0.0 to 3.0	—
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 Swelling: Grade 4	0.0 percentage of participants Interval 0.0 to 5.9	0.0 percentage of participants Interval 0.0 to 2.0	0.0 percentage of participants Interval 0.0 to 2.0	—

Measure	Placebo: Day 1, 8 and 30 Regimen n=16 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=18 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=24 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=20 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	66.7 percentage of participants Interval 41.0 to 86.7	0.0 percentage of participants Interval 0.0 to 14.2	70.0 percentage of participants Interval 45.7 to 88.1
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	38.9 percentage of participants Interval 17.3 to 64.3	0.0 percentage of participants Interval 0.0 to 14.2	70.0 percentage of participants Interval 45.7 to 88.1
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	33.3 percentage of participants Interval 13.3 to 59.0	0.0 percentage of participants Interval 0.0 to 14.2	35.0 percentage of participants Interval 15.4 to 59.2
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	88.9 percentage of participants Interval 65.3 to 98.6	0.0 percentage of participants Interval 0.0 to 14.2	85.0 percentage of participants Interval 62.1 to 96.8
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	100.0 percentage of participants Interval 81.5 to 100.0	0.0 percentage of participants Interval 0.0 to 14.2	90.0 percentage of participants Interval 68.3 to 98.8
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	88.9 percentage of participants Interval 65.3 to 98.6	0.0 percentage of participants Interval 0.0 to 14.2	85.0 percentage of participants Interval 62.1 to 96.8
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	72.2 percentage of participants Interval 46.5 to 90.3	0.0 percentage of participants Interval 0.0 to 14.2	75.0 percentage of participants Interval 50.9 to 91.3
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	50.0 percentage of participants Interval 26.0 to 74.0	0.0 percentage of participants Interval 0.0 to 14.2	55.0 percentage of participants Interval 31.5 to 76.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	72.2 percentage of participants Interval 46.5 to 90.3	0.0 percentage of participants Interval 0.0 to 14.8	80.0 percentage of participants Interval 56.3 to 94.3
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	61.1 percentage of participants Interval 35.7 to 82.7	0.0 percentage of participants Interval 0.0 to 14.8	75.0 percentage of participants Interval 50.9 to 91.3
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	44.4 percentage of participants Interval 21.5 to 69.2	0.0 percentage of participants Interval 0.0 to 14.8	40.0 percentage of participants Interval 19.1 to 63.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=4 fold rise	6.3 percentage of participants Interval 0.2 to 30.2	47.1 percentage of participants Interval 23.0 to 72.2	0.0 percentage of participants Interval 0.0 to 16.8	55.0 percentage of participants Interval 31.5 to 76.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	41.2 percentage of participants Interval 18.4 to 67.1	0.0 percentage of participants Interval 0.0 to 16.8	45.0 percentage of participants Interval 23.1 to 68.5
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	11.8 percentage of participants Interval 1.5 to 36.4	0.0 percentage of participants Interval 0.0 to 16.8	15.0 percentage of participants Interval 3.2 to 37.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	11.8 percentage of participants Interval 1.5 to 36.4	0.0 percentage of participants Interval 0.0 to 16.8	5.0 percentage of participants Interval 0.1 to 24.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 19.5	0.0 percentage of participants Interval 0.0 to 16.8	5.3 percentage of participants Interval 0.1 to 26.0
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 23.2	17.6 percentage of participants Interval 3.8 to 43.4	0.0 percentage of participants Interval 0.0 to 16.8	16.7 percentage of participants Interval 3.6 to 41.4
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 23.2	11.8 percentage of participants Interval 1.5 to 36.4	0.0 percentage of participants Interval 0.0 to 16.8	11.1 percentage of participants Interval 1.4 to 34.7
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 24.7	50.0 percentage of participants Interval 24.7 to 75.3	0.0 percentage of participants Interval 0.0 to 16.8	50.0 percentage of participants Interval 26.0 to 74.0
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 24.7	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 16.8	16.7 percentage of participants Interval 3.6 to 41.4
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 24.7	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 16.8	5.6 percentage of participants Interval 0.1 to 27.3
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	16.7 percentage of participants Interval 3.6 to 41.4	0.0 percentage of participants Interval 0.0 to 14.8	25.0 percentage of participants Interval 8.7 to 49.1
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	72.2 percentage of participants Interval 46.5 to 90.3	4.8 percentage of participants Interval 0.1 to 23.8	65.0 percentage of participants Interval 40.8 to 84.6
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	50.0 percentage of participants Interval 26.0 to 74.0	0.0 percentage of participants Interval 0.0 to 16.1	50.0 percentage of participants Interval 27.2 to 72.8
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	27.8 percentage of participants Interval 9.7 to 53.5	0.0 percentage of participants Interval 0.0 to 16.1	30.0 percentage of participants Interval 11.9 to 54.3
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 18.5	0.0 percentage of participants Interval 0.0 to 16.1	5.0 percentage of participants Interval 0.1 to 24.9
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	41.2 percentage of participants Interval 18.4 to 67.1	0.0 percentage of participants Interval 0.0 to 16.8	47.4 percentage of participants Interval 24.4 to 71.1
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	23.5 percentage of participants Interval 6.8 to 49.9	0.0 percentage of participants Interval 0.0 to 16.8	31.6 percentage of participants Interval 12.6 to 56.6
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 19.5	0.0 percentage of participants Interval 0.0 to 16.8	15.8 percentage of participants Interval 3.4 to 39.6
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 23.2	29.4 percentage of participants Interval 10.3 to 56.0	0.0 percentage of participants Interval 0.0 to 16.8	38.9 percentage of participants Interval 17.3 to 64.3
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 23.2	0.0 percentage of participants Interval 0.0 to 19.5	0.0 percentage of participants Interval 0.0 to 16.8	0.0 percentage of participants Interval 0.0 to 18.5
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 24.7	25.0 percentage of participants Interval 7.3 to 52.4	0.0 percentage of participants Interval 0.0 to 16.8	38.9 percentage of participants Interval 17.3 to 64.3

Measure	Placebo: Day 1, 8 and 30 Regimen n=48 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=52 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=58 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=59 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	67.3 percentage of participants Interval 52.9 to 79.7	0.0 percentage of participants Interval 0.0 to 6.2	55.9 percentage of participants Interval 42.4 to 68.8
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	75.0 percentage of participants Interval 61.1 to 86.0	1.7 percentage of participants Interval 0.0 to 9.2	71.2 percentage of participants Interval 57.9 to 82.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	50.0 percentage of participants Interval 35.8 to 64.2	0.0 percentage of participants Interval 0.0 to 6.2	55.9 percentage of participants Interval 42.4 to 68.8
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	23.1 percentage of participants Interval 12.5 to 36.8	0.0 percentage of participants Interval 0.0 to 6.2	32.2 percentage of participants Interval 20.6 to 45.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	13.5 percentage of participants Interval 5.6 to 25.8	0.0 percentage of participants Interval 0.0 to 6.2	8.5 percentage of participants Interval 2.8 to 18.7
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	94.2 percentage of participants Interval 84.1 to 98.8	0.0 percentage of participants Interval 0.0 to 6.2	84.7 percentage of participants Interval 73.0 to 92.8
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	78.8 percentage of participants Interval 65.3 to 88.9	0.0 percentage of participants Interval 0.0 to 6.2	72.9 percentage of participants Interval 59.7 to 83.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	34.6 percentage of participants Interval 22.0 to 49.1	0.0 percentage of participants Interval 0.0 to 6.2	32.2 percentage of participants Interval 20.6 to 45.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 7.5	70.0 percentage of participants Interval 55.4 to 82.1	1.8 percentage of participants Interval 0.0 to 9.4	61.0 percentage of participants Interval 47.4 to 73.5
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 7.5	44.0 percentage of participants Interval 30.0 to 58.7	1.8 percentage of participants Interval 0.0 to 9.4	39.0 percentage of participants Interval 26.5 to 52.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.5	26.0 percentage of participants Interval 14.6 to 40.3	1.8 percentage of participants Interval 0.0 to 9.4	18.6 percentage of participants Interval 9.7 to 30.9
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.5	4.0 percentage of participants Interval 0.5 to 13.7	0.0 percentage of participants Interval 0.0 to 6.3	0.0 percentage of participants Interval 0.0 to 6.1
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 7.7	52.0 percentage of participants Interval 37.4 to 66.3	0.0 percentage of participants Interval 0.0 to 6.5	36.2 percentage of participants Interval 24.0 to 49.9
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 7.7	28.0 percentage of participants Interval 16.2 to 42.5	0.0 percentage of participants Interval 0.0 to 6.5	24.1 percentage of participants Interval 13.9 to 37.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.7	10.0 percentage of participants Interval 3.3 to 21.8	0.0 percentage of participants Interval 0.0 to 6.5	5.2 percentage of participants Interval 1.1 to 14.4
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.7	0.0 percentage of participants Interval 0.0 to 7.1	0.0 percentage of participants Interval 0.0 to 6.5	0.0 percentage of participants Interval 0.0 to 6.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=4 fold rise	2.3 percentage of participants Interval 0.1 to 12.0	26.5 percentage of participants Interval 14.9 to 41.1	0.0 percentage of participants Interval 0.0 to 6.6	24.1 percentage of participants Interval 13.9 to 37.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 8.0	14.3 percentage of participants Interval 5.9 to 27.2	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 6.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 8.0	2.0 percentage of participants Interval 0.1 to 10.9	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 6.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 8.0	0.0 percentage of participants Interval 0.0 to 7.3	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 6.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=4 fold rise	4.5 percentage of participants Interval 0.6 to 15.5	29.2 percentage of participants Interval 17.0 to 44.1	9.4 percentage of participants Interval 3.1 to 20.7	15.8 percentage of participants Interval 7.5 to 27.9
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=8 fold rise	4.5 percentage of participants Interval 0.6 to 15.5	8.3 percentage of participants Interval 2.3 to 20.0	5.7 percentage of participants Interval 1.2 to 15.7	1.8 percentage of participants Interval 0.0 to 9.4
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 8.0	0.0 percentage of participants Interval 0.0 to 7.4	0.0 percentage of participants Interval 0.0 to 6.7	1.8 percentage of participants Interval 0.0 to 9.4
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 8.0	0.0 percentage of participants Interval 0.0 to 7.4	0.0 percentage of participants Interval 0.0 to 6.7	0.0 percentage of participants Interval 0.0 to 6.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 8.6	13.3 percentage of participants Interval 5.1 to 26.8	0.0 percentage of participants Interval 0.0 to 7.0	7.3 percentage of participants Interval 2.0 to 17.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 8.6	6.7 percentage of participants Interval 1.4 to 18.3	0.0 percentage of participants Interval 0.0 to 7.0	7.3 percentage of participants Interval 2.0 to 17.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 8.6	2.2 percentage of participants Interval 0.1 to 11.8	0.0 percentage of participants Interval 0.0 to 7.0	3.6 percentage of participants Interval 0.4 to 12.5
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 8.6	0.0 percentage of participants Interval 0.0 to 7.9	0.0 percentage of participants Interval 0.0 to 7.0	0.0 percentage of participants Interval 0.0 to 6.5
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=4 fold rise	2.4 percentage of participants Interval 0.1 to 12.9	18.2 percentage of participants Interval 8.2 to 32.7	0.0 percentage of participants Interval 0.0 to 7.1	17.0 percentage of participants Interval 8.1 to 29.8
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 8.6	2.3 percentage of participants Interval 0.1 to 12.0	0.0 percentage of participants Interval 0.0 to 7.1	1.9 percentage of participants Interval 0.0 to 10.1
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 8.6	2.3 percentage of participants Interval 0.1 to 12.0	0.0 percentage of participants Interval 0.0 to 7.1	0.0 percentage of participants Interval 0.0 to 6.7
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 8.6	0.0 percentage of participants Interval 0.0 to 8.0	0.0 percentage of participants Interval 0.0 to 7.1	0.0 percentage of participants Interval 0.0 to 6.7

Measure	Placebo: Day 1, 8 and 30 Regimen n=48 Participants Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen n=52 Participants Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination	Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen n=58 Participants Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.	200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen n=59 Participants Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	65.4 percentage of participants Interval 50.9 to 78.0	0.0 percentage of participants Interval 0.0 to 6.2	69.5 percentage of participants Interval 56.1 to 80.8
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	48.1 percentage of participants Interval 34.0 to 62.4	0.0 percentage of participants Interval 0.0 to 6.2	54.2 percentage of participants Interval 40.8 to 67.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	26.9 percentage of participants Interval 15.6 to 41.0	0.0 percentage of participants Interval 0.0 to 6.2	37.3 percentage of participants Interval 25.0 to 50.9
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 8: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	13.5 percentage of participants Interval 5.6 to 25.8	0.0 percentage of participants Interval 0.0 to 6.2	11.9 percentage of participants Interval 4.9 to 22.9
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	80.8 percentage of participants Interval 67.5 to 90.4	0.0 percentage of participants Interval 0.0 to 6.2	81.4 percentage of participants Interval 69.1 to 90.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	65.4 percentage of participants Interval 50.9 to 78.0	0.0 percentage of participants Interval 0.0 to 6.2	64.4 percentage of participants Interval 50.9 to 76.4
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	51.9 percentage of participants Interval 37.6 to 66.0	0.0 percentage of participants Interval 0.0 to 6.2	50.8 percentage of participants Interval 37.5 to 64.1
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Day 30: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.4	34.6 percentage of participants Interval 22.0 to 49.1	0.0 percentage of participants Interval 0.0 to 6.2	30.5 percentage of participants Interval 19.2 to 43.9
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.5	22.0 percentage of participants Interval 11.5 to 36.0	1.8 percentage of participants Interval 0.0 to 9.4	11.9 percentage of participants Interval 4.9 to 22.9
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 7.7	46.0 percentage of participants Interval 31.8 to 60.7	1.8 percentage of participants Interval 0.0 to 9.7	32.8 percentage of participants Interval 21.0 to 46.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 7.7	30.0 percentage of participants Interval 17.9 to 44.6	1.8 percentage of participants Interval 0.0 to 9.7	12.1 percentage of participants Interval 5.0 to 23.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=8 fold rise	2.3 percentage of participants Interval 0.1 to 12.0	20.4 percentage of participants Interval 10.2 to 34.3	1.9 percentage of participants Interval 0.0 to 9.9	5.2 percentage of participants Interval 1.1 to 14.4
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=16 fold rise	2.3 percentage of participants Interval 0.1 to 12.0	4.1 percentage of participants Interval 0.5 to 14.0	1.9 percentage of participants Interval 0.0 to 9.9	1.7 percentage of participants Interval 0.0 to 9.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=8 fold rise	13.6 percentage of participants Interval 5.2 to 27.4	16.7 percentage of participants Interval 7.5 to 30.2	5.7 percentage of participants Interval 1.2 to 15.7	5.3 percentage of participants Interval 1.1 to 14.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=4 fold rise	7.3 percentage of participants Interval 1.5 to 19.9	31.1 percentage of participants Interval 18.2 to 46.6	3.9 percentage of participants Interval 0.5 to 13.5	18.2 percentage of participants Interval 9.1 to 30.9
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=8 fold rise	4.9 percentage of participants Interval 0.6 to 16.5	15.6 percentage of participants Interval 6.5 to 29.5	2.0 percentage of participants Interval 0.0 to 10.4	7.3 percentage of participants Interval 2.0 to 17.6
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=16 fold rise	2.4 percentage of participants Interval 0.1 to 12.9	6.7 percentage of participants Interval 1.4 to 18.3	2.0 percentage of participants Interval 0.0 to 10.4	3.6 percentage of participants Interval 0.4 to 12.5
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 30: >=32 fold rise	2.4 percentage of participants Interval 0.1 to 12.9	4.4 percentage of participants Interval 0.5 to 15.1	0.0 percentage of participants Interval 0.0 to 7.0	1.8 percentage of participants Interval 0.0 to 9.7
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=4 fold rise	9.8 percentage of participants Interval 2.7 to 23.1	36.4 percentage of participants Interval 22.4 to 52.2	2.0 percentage of participants Interval 0.1 to 10.6	13.2 percentage of participants Interval 5.5 to 25.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=8 fold rise	4.9 percentage of participants Interval 0.6 to 16.5	13.6 percentage of participants Interval 5.2 to 27.4	2.0 percentage of participants Interval 0.1 to 10.6	1.9 percentage of participants Interval 0.0 to 10.1
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=32 fold rise	2.4 percentage of participants Interval 0.1 to 12.9	4.5 percentage of participants Interval 0.6 to 15.5	0.0 percentage of participants Interval 0.0 to 7.1	0.0 percentage of participants Interval 0.0 to 6.7
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=4 fold rise	0.0 percentage of participants Interval 0.0 to 7.5	64.0 percentage of participants Interval 49.2 to 77.1	3.5 percentage of participants Interval 0.4 to 12.1	57.6 percentage of participants Interval 44.1 to 70.4
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=8 fold rise	0.0 percentage of participants Interval 0.0 to 7.5	38.0 percentage of participants Interval 24.7 to 52.8	1.8 percentage of participants Interval 0.0 to 9.4	35.6 percentage of participants Interval 23.6 to 49.1
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 6: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.5	12.0 percentage of participants Interval 4.5 to 24.3	1.8 percentage of participants Interval 0.0 to 9.7	3.4 percentage of participants Interval 0.4 to 11.7
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=16 fold rise	0.0 percentage of participants Interval 0.0 to 7.7	14.0 percentage of participants Interval 5.8 to 26.7	1.8 percentage of participants Interval 0.0 to 9.7	5.2 percentage of participants Interval 1.1 to 14.4
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 12: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 7.7	4.0 percentage of participants Interval 0.5 to 13.7	1.8 percentage of participants Interval 0.0 to 9.7	1.7 percentage of participants Interval 0.0 to 9.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=4 fold rise	6.8 percentage of participants Interval 1.4 to 18.7	32.7 percentage of participants Interval 19.9 to 47.5	1.9 percentage of participants Interval 0.0 to 9.9	12.1 percentage of participants Interval 5.0 to 23.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 18: >=32 fold rise	0.0 percentage of participants Interval 0.0 to 8.0	2.0 percentage of participants Interval 0.1 to 10.9	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 6.2
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=4 fold rise	20.5 percentage of participants Interval 9.8 to 35.3	31.3 percentage of participants Interval 18.7 to 46.3	7.5 percentage of participants Interval 2.1 to 18.2	12.3 percentage of participants Interval 5.1 to 23.7
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=16 fold rise	9.1 percentage of participants Interval 2.5 to 21.7	6.3 percentage of participants Interval 1.3 to 17.2	5.7 percentage of participants Interval 1.2 to 15.7	1.8 percentage of participants Interval 0.0 to 9.4
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 24: >=32 fold rise	6.8 percentage of participants Interval 1.4 to 18.7	6.3 percentage of participants Interval 1.3 to 17.2	1.9 percentage of participants Interval 0.0 to 10.1	0.0 percentage of participants Interval 0.0 to 6.3
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 Month 36: >=16 fold rise	4.9 percentage of participants Interval 0.6 to 16.5	6.8 percentage of participants Interval 1.4 to 18.7	0.0 percentage of participants Interval 0.0 to 7.1	0.0 percentage of participants Interval 0.0 to 6.7