Trial Outcomes & Findings for Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years (NCT NCT01511250)

Last Updated: 2023-04-12

Results Overview

Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain \[Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)\] and itching (pruritus) \[Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe\]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (\<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: \>10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

360 participants

Primary outcome timeframe

Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)

Results posted on

2023-04-12

Participant Flow

Participants took part in the study at 8 investigative sites in Puerto Rico, Colombia, Singapore and Thailand from 16 November 2011 to 15 April 2016.

Healthy participants were enrolled in the 2-part study to receive 0.5 mL tetravalent dengue vaccine (TDV) or placebo in 1 of 4 groups for Part I: 21-45 years, 12-20 years, 6-11 years, 1.5-5 years, and in 1 group for Part II: 1.5-11 years. Part II started after all subjects in Part 1 were enrolled.

Participant milestones

Participant milestones
Measure	Part I: TDV 21 to 45 Years TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: TDV 1.5 to 11 Years TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part II: Placebo 1.5 to 11 Years TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Overall Study STARTED	24	14	22	14	21	17	23	13	159	53
Overall Study COMPLETED	15	9	18	11	21	17	21	9	145	48
Overall Study NOT COMPLETED	9	5	4	3	0	0	2	4	14	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Part I: TDV 21 to 45 Years TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 1.5 to 5 Years TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: TDV 1.5 to 11 Years TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part II: Placebo 1.5 to 11 Years TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Overall Study Withdrawal of Consent	1	0	0	0	0	1	1	0
Overall Study Sponsor/Investigator Decision	1	0	0	0	0	0	0	0
Overall Study Lost to Follow-up	7	3	3	3	2	3	13	5
Overall Study Protocol Violation	0	2	1	0	0	0	0	0

Baseline Characteristics

Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part I: TDV 21 to 45 Years n=24 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=23 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=13 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: TDV 1.5 to 11 Years n=159 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part II: Placebo 1.5 to 11 Years n=53 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Total n=360 Participants Total of all reporting groups
Age, Continuous	29.2 years n=5 Participants	30.1 years n=7 Participants	15.5 years n=5 Participants	16.8 years n=4 Participants	8.4 years n=21 Participants	7.8 years n=8 Participants	3.3 years n=8 Participants	3.5 years n=24 Participants	6.6 years n=42 Participants	6.8 years n=42 Participants	9.8 years n=42 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	8 Participants n=8 Participants	7 Participants n=8 Participants	7 Participants n=24 Participants	88 Participants n=42 Participants	19 Participants n=42 Participants	172 Participants n=42 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	7 Participants n=4 Participants	15 Participants n=21 Participants	9 Participants n=8 Participants	16 Participants n=8 Participants	6 Participants n=24 Participants	71 Participants n=42 Participants	34 Participants n=42 Participants	188 Participants n=42 Participants
Race Asian	3 participants n=5 Participants	3 participants n=7 Participants	16 participants n=5 Participants	8 participants n=4 Participants	16 participants n=21 Participants	12 participants n=8 Participants	12 participants n=8 Participants	6 participants n=24 Participants	77 participants n=42 Participants	24 participants n=42 Participants	177 participants n=42 Participants
Race Hispanic or Latino	20 participants n=5 Participants	10 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	4 participants n=21 Participants	5 participants n=8 Participants	11 participants n=8 Participants	7 participants n=24 Participants	79 participants n=42 Participants	27 participants n=42 Participants	175 participants n=42 Participants
Race White	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	3 participants n=42 Participants
Race Black or African American	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	0 participants n=24 Participants	3 participants n=42 Participants	2 participants n=42 Participants	5 participants n=42 Participants
Seropositive to any Serotype at Day 0 Seropositive to any Serotype=No	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants	1 participants n=4 Participants	12 participants n=21 Participants	14 participants n=8 Participants	16 participants n=8 Participants	12 participants n=24 Participants	93 participants n=42 Participants	24 participants n=42 Participants	186 participants n=42 Participants
Seropositive to any Serotype at Day 0 Seropositive to any Serotype=Yes	19 participants n=5 Participants	12 participants n=7 Participants	15 participants n=5 Participants	13 participants n=4 Participants	9 participants n=21 Participants	3 participants n=8 Participants	7 participants n=8 Participants	1 participants n=24 Participants	66 participants n=42 Participants	29 participants n=42 Participants	174 participants n=42 Participants
Height	1.68 meters (m) n=5 Participants	1.65 meters (m) n=7 Participants	1.58 meters (m) n=5 Participants	1.60 meters (m) n=4 Participants	1.29 meters (m) n=21 Participants	1.27 meters (m) n=8 Participants	0.98 meters (m) n=8 Participants	0.99 meters (m) n=24 Participants	1.20 meters (m) n=42 Participants	1.22 meters (m) n=42 Participants	1.28 meters (m) n=42 Participants
Weight	81.6 kilograms (kg) n=5 Participants	80.2 kilograms (kg) n=7 Participants	57.0 kilograms (kg) n=5 Participants	59.5 kilograms (kg) n=4 Participants	31.2 kilograms (kg) n=21 Participants	27.0 kilograms (kg) n=8 Participants	15.1 kilograms (kg) n=8 Participants	16.5 kilograms (kg) n=24 Participants	25.7 kilograms (kg) n=42 Participants	26.7 kilograms (kg) n=42 Participants	34.3 kilograms (kg) n=42 Participants
Body Mass Index (BMI)	28.81 kg/m^2 n=5 Participants	29.05 kg/m^2 n=7 Participants	22.60 kg/m^2 n=5 Participants	23.09 kg/m^2 n=4 Participants	18.38 kg/m^2 n=21 Participants	16.56 kg/m^2 n=8 Participants	15.63 kg/m^2 n=8 Participants	16.95 kg/m^2 n=24 Participants	17.02 kg/m^2 n=42 Participants	17.08 kg/m^2 n=42 Participants	18.83 kg/m^2 n=42 Participants

PRIMARY outcome

Timeframe: Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)

Population: The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.

Outcome measures

Outcome measures
Measure	Part II: TDV 1.5 to 11 Years n=159 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: TDV 21 to 45 Years n=24 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=23 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=13 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: Placebo 1.5 to 11 Years n=53 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Pain, Any Severity	56 participants	7 participants	0 participants	14 participants	3 participants	9 participants	0 participants	7 participants	2 participants	6 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Edema, Grade 3	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Pain, Grade 2	11 participants	0 participants	0 participants	3 participants	1 participants	4 participants	0 participants	0 participants	0 participants	3 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Pain, Grade 1	41 participants	7 participants	0 participants	11 participants	2 participants	4 participants	0 participants	7 participants	2 participants	3 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Pain, Grade 3	4 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Itching, Any Severity	26 participants	3 participants	1 participants	7 participants	1 participants	2 participants	1 participants	2 participants	0 participants	4 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Itching, Grade 1	19 participants	3 participants	1 participants	7 participants	1 participants	1 participants	1 participants	2 participants	0 participants	3 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Itching, Grade 2	6 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Itching, Grade 3	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Erythema, Any Severity	24 participants	6 participants	0 participants	4 participants	0 participants	2 participants	0 participants	3 participants	0 participants	1 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Erythema, Grade 1	21 participants	5 participants	0 participants	4 participants	0 participants	1 participants	0 participants	3 participants	0 participants	0 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Erythema, Grade 2	2 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Erythema, Grade 3	1 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Edema, Any Severity	13 participants	0 participants	0 participants	1 participants	0 participants	3 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Edema, Grade 1	9 participants	0 participants	0 participants	1 participants	0 participants	3 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Edema, Grade 2	3 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Within 28 days after either of the vaccination given on Day 0 or 90 (Day 28 for first vaccination, Day 118 for second vaccination)

Population: The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.

Outcome measures

Outcome measures
Measure	Part II: TDV 1.5 to 11 Years n=159 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: TDV 21 to 45 Years n=24 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=23 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=13 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: Placebo 1.5 to 11 Years n=53 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity Pain, Any Severity	33 participants	2 participants	0 participants	4 participants	2 participants	9 participants	5 participants	5 participants	1 participants	14 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity Pain, Grade 2	3 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity Pain, Grade 1	28 participants	2 participants	0 participants	3 participants	2 participants	9 participants	5 participants	5 participants	1 participants	13 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity Itching, Any Severity	4 participants	2 participants	2 participants	2 participants	1 participants	1 participants	1 participants	1 participants	0 participants	5 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity Itching, Grade 1	4 participants	2 participants	2 participants	2 participants	1 participants	1 participants	1 participants	1 participants	0 participants	5 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity Erythema, Any Severity	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity Edema, Any Severity	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)

Population: The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.

Solicited systemic AEs (headache, muscle pain \[myalgia\], joint pain \[arthralgia\], eye pain, sensitivity to light \[photophobia\], tiredness \[fatigue\], body rash, nausea, were recorded in the participant's-diary along with vomiting \[number of times\]), and body temperature). Diary-recorded severity grades were based on the Common Terminology Criteria for Adverse Events (CTCAE). Severity grades were: Mild (Grade 1): transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities. The CTCAE severity grades for fever and vomiting were derived from the diary-recorded measurements of temperature level and number of episodes, respectively.

Outcome measures

Outcome measures
Measure	Part II: TDV 1.5 to 11 Years n=159 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: TDV 21 to 45 Years n=24 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=23 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=13 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: Placebo 1.5 to 11 Years n=53 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Headache, Grade 3	4 participants	1 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	2 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Headache, Grade 1	30 participants	3 participants	1 participants	4 participants	5 participants	3 participants	3 participants	3 participants	3 participants	6 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Myalgia, Any Severity	30 participants	4 participants	3 participants	4 participants	5 participants	1 participants	3 participants	5 participants	2 participants	6 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Myalgia, Grade 2	6 participants	0 participants	1 participants	2 participants	2 participants	0 participants	0 participants	2 participants	1 participants	1 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Eye Pain, Grade 1	11 participants	1 participants	2 participants	0 participants	2 participants	0 participants	0 participants	2 participants	1 participants	3 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Fatigue, Grade 2	7 participants	0 participants	0 participants	2 participants	4 participants	0 participants	3 participants	2 participants	0 participants	3 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Body rash, Grade 1	12 participants	1 participants	0 participants	1 participants	1 participants	2 participants	1 participants	2 participants	2 participants	2 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Nausea, Grade 1	14 participants	2 participants	1 participants	3 participants	2 participants	0 participants	0 participants	2 participants	3 participants	4 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Nausea, Grade 3	4 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Vomiting, Any Severity	18 participants	2 participants	1 participants	0 participants	2 participants	1 participants	1 participants	4 participants	5 participants	3 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Vomiting, Grade 1	5 participants	0 participants	1 participants	0 participants	2 participants	0 participants	1 participants	1 participants	2 participants	2 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Vomiting, Grade 3	2 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Fever, Any Severity	33 participants	1 participants	3 participants	4 participants	1 participants	1 participants	1 participants	4 participants	4 participants	9 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Fever, Grade 1	27 participants	0 participants	1 participants	4 participants	1 participants	1 participants	1 participants	4 participants	2 participants	6 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Fever, Grade 2	5 participants	1 participants	2 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	2 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Fever, Grade 3	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Headache, Any Grade	46 participants	6 participants	4 participants	9 participants	8 participants	4 participants	5 participants	3 participants	4 participants	12 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Headache, Grade 2	12 participants	2 participants	2 participants	5 participants	3 participants	1 participants	2 participants	0 participants	1 participants	4 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Myalgia, Grade 1	21 participants	3 participants	1 participants	2 participants	2 participants	1 participants	3 participants	3 participants	0 participants	4 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Myalgia, Grade 3	3 participants	1 participants	1 participants	0 participants	1 participants	0 participants	0 participants	0 participants	1 participants	1 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Arthralgia, Any Severity	10 participants	1 participants	3 participants	2 participants	2 participants	0 participants	0 participants	1 participants	1 participants	2 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Arthralgia, Grade 1	7 participants	1 participants	1 participants	1 participants	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Arthralgia, Grade 2	3 participants	0 participants	1 participants	1 participants	2 participants	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Arthralgia, Grade 3	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Eye Pain, Any Severity	14 participants	3 participants	3 participants	1 participants	3 participants	0 participants	0 participants	2 participants	1 participants	3 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Eye Pain, Grade 2	3 participants	1 participants	0 participants	1 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Eye Pain, Grade 3	0 participants	1 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Photophobia, Any Severity	11 participants	3 participants	1 participants	0 participants	4 participants	1 participants	0 participants	0 participants	0 participants	3 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Photophobia, Grade 1	9 participants	1 participants	1 participants	0 participants	4 participants	0 participants	0 participants	0 participants	0 participants	3 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Photophobia, Grade 2	2 participants	1 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Photophobia, Grade 3	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Fatigue, Any Severity	29 participants	4 participants	4 participants	9 participants	6 participants	2 participants	5 participants	3 participants	3 participants	10 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Nausea, Grade 2	4 participants	1 participants	0 participants	0 participants	2 participants	1 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Fatigue, Grade 1	19 participants	2 participants	2 participants	7 participants	2 participants	1 participants	2 participants	1 participants	2 participants	6 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Fatigue, Grade 3	3 participants	2 participants	2 participants	0 participants	0 participants	1 participants	0 participants	0 participants	1 participants	1 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Body rash, Any Severity	14 participants	1 participants	0 participants	2 participants	2 participants	2 participants	1 participants	2 participants	2 participants	2 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Body rash, Grade 2	1 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Body rash, Grade 3	1 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Nausea, Any Severity	22 participants	4 participants	1 participants	3 participants	4 participants	1 participants	0 participants	3 participants	3 participants	4 participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity Vomiting, Grade 2	11 participants	1 participants	0 participants	0 participants	0 participants	1 participants	0 participants	3 participants	3 participants	1 participants

PRIMARY outcome

Timeframe: Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)

Population: The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited local injection site reactions included pain, itching, erythema, edema and solicited systemic AEs include myalgia, arthralgia, eye pain, photophobia, fatigue, body rash, nausea, vomiting, and fever.

Outcome measures

Outcome measures
Measure	Part II: TDV 1.5 to 11 Years n=159 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: TDV 21 to 45 Years n=24 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=23 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=13 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: Placebo 1.5 to 11 Years n=53 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Number of Participants With Any Solicited AE Following Either Vaccination Dose	110 participants	13 participants	9 participants	17 participants	12 participants	12 participants	8 participants	17 participants	10 participants	28 participants

PRIMARY outcome

Timeframe: Unsolicited AEs were collected within 28 days of all vaccinations. Serious AEs were collected throughout the study up to Day 1080

Population: The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The severity of all unsolicited AEs was evaluated by the Investigator (using the Common Terminology Criteria for Adverse Events \[CTCAE\] v4.03) as follows. Mild (Grade 1): Transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): Marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities.

Outcome measures

Outcome measures
Measure	Part II: TDV 1.5 to 11 Years n=159 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: TDV 21 to 45 Years n=24 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=23 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=13 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: Placebo 1.5 to 11 Years n=53 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity At least one unsolicited AE	101 participants	13 participants	7 participants	14 participants	8 participants	12 participants	11 participants	17 participants	12 participants	37 participants
Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity Unsolicited AEs by worst severity, Moderate	25 participants	5 participants	5 participants	6 participants	5 participants	1 participants	3 participants	4 participants	2 participants	6 participants
Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity Unsolicited AEs by worst severity, Mild	72 participants	6 participants	2 participants	7 participants	2 participants	10 participants	8 participants	13 participants	10 participants	31 participants
Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity Unsolicited AEs by worst severity, Severe	4 participants	2 participants	0 participants	1 participants	1 participants	1 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: 30 days after second vaccination (Day 120)

Population: FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample has been received.

Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 for any serotype and seronegative was defined as titre value of less than (\<) 10 for all 4 serotypes. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.

Outcome measures

Outcome measures
Measure	Part II: TDV 1.5 to 11 Years n=156 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: TDV 21 to 45 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=13 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=11 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: Placebo 1.5 to 11 Years n=53 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120 TDV-1	100.0 percentage of participants Interval 97.7 to 100.0	100.0 percentage of participants Interval 84.6 to 100.0	92.3 percentage of participants Interval 64.0 to 99.8	100.0 percentage of participants Interval 84.6 to 100.0	85.7 percentage of participants Interval 57.2 to 98.2	100.0 percentage of participants Interval 83.9 to 100.0	23.5 percentage of participants Interval 6.8 to 49.9	100.0 percentage of participants Interval 84.6 to 100.0	0.0 percentage of participants Interval 0.0 to 28.5	43.4 percentage of participants Interval 29.8 to 57.7
Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120 TDV-2	100.0 percentage of participants Interval 97.7 to 100.0	100.0 percentage of participants Interval 84.6 to 100.0	84.6 percentage of participants Interval 54.6 to 98.1	95.5 percentage of participants Interval 77.2 to 99.9	85.7 percentage of participants Interval 57.2 to 98.2	100.0 percentage of participants Interval 83.9 to 100.0	23.5 percentage of participants Interval 6.8 to 49.9	100.0 percentage of participants Interval 84.6 to 100.0	0.0 percentage of participants Interval 0.0 to 28.5	35.8 percentage of participants Interval 23.1 to 50.2
Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120 TDV-3	99.4 percentage of participants Interval 96.5 to 100.0	100.0 percentage of participants Interval 84.6 to 100.0	100.0 percentage of participants Interval 75.3 to 100.0	100.0 percentage of participants Interval 84.6 to 100.0	85.7 percentage of participants Interval 57.2 to 98.2	100.0 percentage of participants Interval 83.9 to 100.0	29.4 percentage of participants Interval 10.3 to 56.0	100.0 percentage of participants Interval 84.6 to 100.0	0.0 percentage of participants Interval 0.0 to 28.5	35.8 percentage of participants Interval 23.1 to 50.2
Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120 TDV-4	94.9 percentage of participants Interval 90.1 to 97.8	90.9 percentage of participants Interval 70.8 to 98.9	61.5 percentage of participants Interval 31.6 to 86.1	72.7 percentage of participants Interval 49.8 to 89.3	71.4 percentage of participants Interval 41.9 to 91.6	85.7 percentage of participants Interval 63.7 to 97.0	29.4 percentage of participants Interval 10.3 to 56.0	100.0 percentage of participants Interval 84.6 to 100.0	0.0 percentage of participants Interval 0.0 to 28.5	35.8 percentage of participants Interval 23.1 to 50.2

SECONDARY outcome

Timeframe: Days 0, 7, 14, 90, 97, and 104

Population: The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.

Vaccine viremia was assessed for each of the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4 for Part-1. Vaccine viral ribonucleic acid (RNA) was detected by a quantitative reverse transcription-polymerase chain reaction (qRT-PCR) assay.

Outcome measures

Outcome measures
Measure	Part II: TDV 1.5 to 11 Years TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: TDV 21 to 45 Years n=24 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=23 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=13 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: Placebo 1.5 to 11 Years TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 7, TDV-3	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 0, TDV-1	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 0, TDV-2	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 0, TDV-3	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 0, TDV-4	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 7, TDV-1	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 7, TDV-2	—	2 participants	0 participants	4 participants	0 participants	4 participants	0 participants	9 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 7, TDV-4	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 14, TDV-1	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 14, TDV-2	—	0 participants	0 participants	3 participants	0 participants	6 participants	0 participants	4 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 14, TDV-3	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 14, TDV-4	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 90, TDV-1	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 90, TDV-2	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 90, TDV-3	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 90, TDV-4	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 97, TDV-1	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 97, TDV-2	—	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 97, TDV-3	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 97, TDV-4	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 104, TDV-1	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 104, TDV-2	—	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 104, TDV-3	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination Day 104, TDV-4	—	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Day 28 and Day 90 (Parts 1 and 2) and Days 120, 180, 360, 720 and 1080 in Part 1

Outcome measures

Outcome measures
Measure	Part II: TDV 1.5 to 11 Years n=159 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: TDV 21 to 45 Years n=24 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=23 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=13 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: Placebo 1.5 to 11 Years n=53 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 720, TDV-3	—	3.15 fold rise Interval 1.38 to 7.21	0.93 fold rise Interval 0.67 to 1.28	2.00 fold rise Interval 0.76 to 5.28	1.21 fold rise Interval 0.72 to 2.02	5.04 fold rise Interval 2.21 to 11.5	1.06 fold rise Interval 0.8 to 1.41	10.79 fold rise Interval 4.16 to 28.0	1.62 fold rise Interval 0.54 to 4.87	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 720, TDV-2	—	9.13 fold rise Interval 2.52 to 33.07	0.80 fold rise Interval 0.51 to 1.24	8.61 fold rise Interval 3.28 to 22.56	0.88 fold rise Interval 0.52 to 1.48	21.53 fold rise Interval 9.91 to 46.81	1.30 fold rise Interval 0.73 to 2.32	24.10 fold rise Interval 11.73 to 49.52	1.07 fold rise Interval 0.92 to 1.25	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 28, TDV-1	27.58 fold rise Interval 20.91 to 36.38	3.41 fold rise Interval 1.61 to 7.24	0.90 fold rise Interval 0.57 to 1.41	8.93 fold rise Interval 3.61 to 22.09	1.03 fold rise Interval 0.67 to 1.56	29.47 fold rise Interval 11.7 to 74.22	1.00 fold rise Interval 0.88 to 1.13	27.94 fold rise Interval 13.64 to 57.23	1.05 fold rise Interval 0.94 to 1.18	0.97 fold rise Interval 0.82 to 1.16
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 90, TDV-2	463.5 fold rise Interval 364.0 to 590.2	7.09 fold rise Interval 2.2 to 22.83	1.27 fold rise Interval 0.78 to 2.08	13.45 fold rise Interval 4.52 to 40.08	1.16 fold rise Interval 0.74 to 1.83	74.25 fold rise Interval 30.35 to 181.64	1.00 fold rise Interval 0.88 to 1.13	51.33 fold rise Interval 20.33 to 129.62	1.00 fold rise Lower and upper limits of CI could not be evaluated as titers were below the LLOD.	15.2 fold rise Interval 8.9 to 25.9
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 1080, TDV-3	—	1.87 fold rise Interval 0.98 to 3.54	1.04 fold rise Interval 0.75 to 1.45	2.33 fold rise Interval 0.97 to 5.59	1.17 fold rise Interval 0.65 to 2.1	5.38 fold rise Interval 2.71 to 10.71	1.15 fold rise Interval 0.89 to 1.5	8.55 fold rise Interval 3.97 to 18.38	1.85 fold rise Interval 0.45 to 7.67	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 28, TDV-2	113.02 fold rise Interval 0.1 to 8192.0	7.89 fold rise Interval 2.01 to 31.0	0.71 fold rise Interval 0.45 to 1.11	20.26 fold rise Interval 5.34 to 76.93	1.05 fold rise Interval 0.69 to 1.59	181.02 fold rise Interval 47.86 to 684.6	1.39 fold rise Interval 0.81 to 2.37	128.00 fold rise Interval 44.62 to 367.22	1.00 fold rise Lower and upper limits of CI could not be evaluated as titers were below the lower limit of detection (LLOD).	0.94 fold rise Interval 0.0 to 2.0
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 28, TDV-3	12.47 fold rise Interval 9.18 to 16.92	2.34 fold rise Interval 1.22 to 4.52	0.97 fold rise Interval 0.74 to 1.28	4.40 fold rise Interval 1.85 to 10.48	1.08 fold rise Interval 0.71 to 1.63	24.17 fold rise Interval 10.16 to 57.49	1.02 fold rise Interval 0.98 to 1.07	13.76 fold rise Interval 6.01 to 31.5	1.00 fold rise Lower and upper limits of CI could not be evaluated as titers were below the LLOD.	0.82 fold rise Interval 0.71 to 0.94
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 28, TDV-4	74.1 fold rise Interval 66.5 to 80.7	1.71 fold rise Interval 0.88 to 3.31	1.11 fold rise Interval 0.65 to 1.9	2.74 fold rise Interval 1.11 to 6.8	0.82 fold rise Interval 0.53 to 1.26	7.49 fold rise Interval 3.6 to 15.58	1.13 fold rise Interval 0.94 to 1.36	4.00 fold rise Interval 1.85 to 8.66	0.95 fold rise Interval 0.84 to 1.06	35.8 fold rise Interval 23.1 to 50.2
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 720, TDV-4	—	1.54 fold rise Interval 0.77 to 3.1	0.56 fold rise Interval 0.39 to 0.82	2.88 fold rise Interval 1.41 to 5.9	1.62 fold rise Interval 0.76 to 3.43	2.97 fold rise Interval 1.56 to 5.66	1.33 fold rise Interval 0.95 to 1.86	3.88 fold rise Interval 1.89 to 7.96	1.07 fold rise Interval 0.74 to 1.55	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 1080, TDV-1	—	3.91 fold rise Interval 1.4 to 10.94	0.77 fold rise Interval 0.45 to 1.31	3.43 fold rise Interval 1.66 to 7.08	1.33 fold rise Interval 0.73 to 2.41	7.13 fold rise Interval 3.86 to 13.17	1.13 fold rise Interval 0.79 to 1.62	9.59 fold rise Interval 4.72 to 19.48	1.26 fold rise Interval 0.74 to 2.15	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 1080, TDV-2	—	4.59 fold rise Interval 1.45 to 14.59	0.68 fold rise Interval 0.51 to 0.9	6.35 fold rise Interval 2.54 to 15.87	0.83 fold rise Interval 0.51 to 1.34	12.29 fold rise Interval 5.76 to 26.22	1.28 fold rise Interval 0.73 to 2.24	12.70 fold rise Interval 5.92 to 27.25	1.00 fold rise Lower and upper limits of CI could not be evaluated as titers were below the LLOD.	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 1080, TDV-4	—	1.15 fold rise Interval 0.71 to 1.87	1.00 fold rise Interval 0.58 to 1.71	2.42 fold rise Interval 1.18 to 4.98	1.46 fold rise Interval 0.66 to 3.21	2.14 fold rise Interval 1.23 to 3.72	1.13 fold rise Interval 0.94 to 1.36	2.44 fold rise Interval 1.4 to 4.25	1.00 fold rise Interval 0.77 to 1.31	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 90, TDV-1	324.2 fold rise Interval 239.1 to 439.6	3.10 fold rise Interval 1.26 to 7.59	1.70 fold rise Interval 0.75 to 3.9	5.40 fold rise Interval 2.5 to 11.63	1.08 fold rise Interval 0.71 to 1.63	18.87 fold rise Interval 7.61 to 46.81	0.96 fold rise Interval 0.88 to 1.05	11.14 fold rise Interval 5.37 to 23.09	1.000 fold rise Lower and upper limits of CI could not be evaluated as titers were below the LLOD.	27.9 fold rise Interval 14.6 to 53.4
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 90, TDV-3	139.5 fold rise Interval 99.7 to 195.1	2.29 fold rise Interval 1.29 to 4.05	1.17 fold rise Interval 0.74 to 1.85	2.57 fold rise Interval 1.14 to 5.8	1.19 fold rise Interval 0.67 to 2.13	14.98 fold rise Interval 6.11 to 36.75	1.02 fold rise Interval 0.92 to 1.13	6.83 fold rise Interval 3.13 to 14.93	1.07 fold rise Interval 0.93 to 1.23	17.1 fold rise Interval 10.2 to 28.5
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 90, TDV-4	33.7 fold rise Interval 25.4 to 44.7	1.64 fold rise Interval 1.02 to 2.66	0.73 fold rise Interval 0.52 to 1.01	3.70 fold rise Interval 1.78 to 7.66	1.22 fold rise Interval 0.72 to 2.07	3.81 fold rise Interval 1.73 to 8.36	1.18 fold rise Interval 0.9 to 1.54	2.45 fold rise Interval 1.39 to 4.32	1.00 fold rise Interval 0.81 to 1.23	11.8 fold rise Interval 8.2 to 16.9
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 120, TDV-1	35.44 fold rise Interval 26.46 to 47.48	3.64 fold rise Interval 1.09 to 12.1	0.81 fold rise Interval 0.56 to 1.16	12.63 fold rise Interval 5.56 to 28.7	0.82 fold rise Interval 0.34 to 2.01	42.36 fold rise Interval 19.57 to 91.7	1.23 fold rise Interval 0.72 to 2.09	39.27 fold rise Interval 24.12 to 63.94	1.00 fold rise Lower and upper limits of CI could not be evaluated as titers were below the LLOD.	1.01 fold rise Interval 0.79 to 1.28
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 120, TDV-2	44.16 fold rise Interval 33.51 to 58.2	8.79 fold rise Interval 2.81 to 27.47	1.08 fold rise Interval 0.79 to 1.49	20.59 fold rise Interval 6.45 to 65.66	1.00 fold rise Interval 0.67 to 1.5	75.48 fold rise Interval 29.82 to 191.08	1.73 fold rise Interval 0.56 to 5.38	50.53 fold rise Interval 24.11 to 105.89	1.00 fold rise Lower and upper limits of CI could not be evaluated as titers were below the LLOD.	0.92 fold rise Interval 0.67 to 1.28
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 120, TDV-3	19.20 fold rise Interval 14.75 to 24.98	2.78 fold rise Interval 1.44 to 5.37	1.24 fold rise Interval 0.7 to 2.2	4.54 fold rise Interval 2.02 to 10.17	1.03 fold rise Interval 0.6 to 1.75	28.98 fold rise Interval 14.52 to 57.87	1.73 fold rise Interval 0.73 to 4.14	20.26 fold rise Interval 12.02 to 34.17	1.00 fold rise Lower and upper limits of CI could not be evaluated as titers were below the LLOD.	0.80 fold rise Interval 0.64 to 1.01
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 120, TDV-4	7.43 fold rise Interval 5.96 to 9.27	2.45 fold rise Interval 1.44 to 4.19	0.73 fold rise Interval 0.43 to 1.23	4.00 fold rise Interval 2.0 to 8.0	1.22 fold rise Interval 0.72 to 2.07	7.87 fold rise Interval 4.25 to 14.57	2.17 fold rise Interval 0.99 to 4.76	6.02 fold rise Interval 3.81 to 9.53	0.94 fold rise Interval 0.82 to 1.08	1.03 fold rise Interval 0.91 to 1.16
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 180, TDV-1	—	3.94 fold rise Interval 1.35 to 11.54	0.89 fold rise Interval 0.59 to 1.35	9.16 fold rise Interval 2.89 to 29.05	0.71 fold rise Interval 0.45 to 1.1	17.70 fold rise Interval 10.04 to 31.22	1.13 fold rise Interval 0.77 to 1.66	16.81 fold rise Interval 9.56 to 29.53	1.00 fold rise Lower and upper limits of CI could not be evaluated as titers were below the LLOD.	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 180, TDV-2	—	11.53 fold rise Interval 3.61 to 36.83	0.94 fold rise Interval 0.55 to 1.63	17.16 fold rise Interval 5.15 to 57.17	1.03 fold rise Interval 0.58 to 1.84	49.34 fold rise Interval 22.02 to 110.57	1.44 fold rise Interval 0.66 to 3.17	43.89 fold rise Interval 21.22 to 90.8	1.00 fold rise Lower and upper limits of CI could not be evaluated as titers were below the LLOD.	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 180, TDV-3	—	2.42 fold rise Interval 1.23 to 4.76	1.26 fold rise Interval 0.95 to 1.68	4.58 fold rise Interval 1.72 to 12.21	0.73 fold rise Interval 0.44 to 1.2	14.52 fold rise Interval 7.7 to 27.38	1.50 fold rise Interval 0.86 to 2.64	9.66 fold rise Interval 4.84 to 19.3	1.21 fold rise Interval 0.79 to 1.84	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 180, TDV-4	—	2.38 fold rise Interval 1.43 to 3.95	1.00 fold rise Interval 0.63 to 1.58	3.35 fold rise Interval 1.6 to 7.01	0.91 fold rise Interval 0.6 to 1.37	5.76 fold rise Interval 3.14 to 10.55	1.44 fold rise Interval 0.88 to 2.36	4.13 fold rise Interval 2.29 to 7.43	0.94 fold rise Interval 0.82 to 1.08	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 360, TDV-1	—	5.51 fold rise Interval 2.13 to 14.26	0.67 fold rise Interval 0.47 to 0.95	6.17 fold rise Interval 2.36 to 16.14	1.09 fold rise Interval 0.5 to 2.37	10.14 fold rise Interval 4.81 to 21.39	1.39 fold rise Interval 0.91 to 2.12	14.90 fold rise Interval 7.48 to 29.66	1.07 fold rise Interval 0.93 to 1.23	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 360, TDV-2	—	9.04 fold rise Interval 2.76 to 29.6	0.93 fold rise Interval 0.64 to 1.34	9.65 fold rise Interval 3.34 to 27.83	1.16 fold rise Interval 0.54 to 2.46	25.30 fold rise Interval 10.1 to 63.38	1.71 fold rise Interval 0.81 to 3.59	32.84 fold rise Interval 15.76 to 68.42	1.00 fold rise Lower and upper limits of CI could not be evaluated as titers were below the LLOD.	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 360, TDV-3	—	2.56 fold rise Interval 1.21 to 5.39	0.95 fold rise Interval 0.71 to 1.27	2.44 fold rise Interval 1.0 to 5.96	0.83 fold rise Interval 0.44 to 1.57	7.92 fold rise Interval 3.28 to 19.1	1.41 fold rise Interval 0.88 to 2.29	9.28 fold rise Interval 4.55 to 18.92	1.00 fold rise Lower and upper limits of CI could not be evaluated as titers were below the LLOD.	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 360, TDV-4	—	2.32 fold rise Interval 1.15 to 4.7	0.75 fold rise Interval 0.53 to 1.06	3.45 fold rise Interval 1.66 to 7.17	1.03 fold rise Interval 0.45 to 2.38	3.29 fold rise Interval 1.83 to 5.89	1.18 fold rise Interval 0.96 to 1.44	2.92 fold rise Interval 1.71 to 4.98	0.94 fold rise Interval 0.82 to 1.08	—
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes Day 720, TDV-1	—	4.65 fold rise Interval 1.45 to 14.97	0.63 fold rise Interval 0.43 to 0.92	3.65 fold rise Interval 1.68 to 7.96	1.27 fold rise Interval 0.64 to 2.54	8.83 fold rise Interval 4.69 to 16.64	1.13 fold rise Interval 0.87 to 1.46	16.77 fold rise Interval 7.12 to 39.51	1.15 fold rise Interval 0.84 to 1.57	—

SECONDARY outcome

Timeframe: Day 1 to Day 1080

Population: The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).

Dengue fever was assessed in participants who had 3 consecutive days of fever \>38°C and tested positive for dengue virus by polymerase chain reaction (PCR) analysis.

Outcome measures

Outcome measures
Measure	Part II: TDV 1.5 to 11 Years n=159 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: TDV 21 to 45 Years n=24 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=23 Participants TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=13 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: Placebo 1.5 to 11 Years n=53 Participants TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Number of Participants With Confirmed Dengue Fever	2 participants	0 participants	0 participants	1 participants	0 participants	1 participants	0 participants	0 participants	1 participants	1 participants

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part I: TDV 21 to 45 Years n=24 participants at risk TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=14 participants at risk TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 participants at risk TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 participants at risk TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 participants at risk TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 participants at risk TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=23 participants at risk TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=13 participants at risk TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: TDV 1.5 to 11 Years n=159 participants at risk TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part II: Placebo 1.5 to 11 Years n=53 participants at risk TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Hepatobiliary disorders Cholecystitis	4.2% 1/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Cholecystitis acute	4.2% 1/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Incision site haematoma	4.2% 1/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Incision site haemorrhage	4.2% 1/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Child maltreatment syndrome	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	4.2% 1/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Abscess limb	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Appendicitis	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bronchitis	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 3/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Cellulitis	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Dengue fever	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 2/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastritis viral	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastroenteritis	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.1% 5/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 1/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.5% 1/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Influenza	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 2/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Urinary tract infection	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Viral infection	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Other adverse events
Measure	Part I: TDV 21 to 45 Years n=24 participants at risk TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 21 to 45 Years n=14 participants at risk TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.	Part I: TDV 12 to 20 Years n=22 participants at risk TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 12 to 20 Years n=14 participants at risk TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.	Part I: TDV 6 to 11 Years n=21 participants at risk TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 6 to 11 Years n=17 participants at risk TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.	Part I: TDV 1.5 to 5 Years n=23 participants at risk TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part I: Placebo 1.5 to 5 Years n=13 participants at risk TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.	Part II: TDV 1.5 to 11 Years n=159 participants at risk TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\10\^4 PFU, 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.	Part II: Placebo 1.5 to 11 Years n=53 participants at risk TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	16.7% 4/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	31.8% 7/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	17.6% 3/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 1/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.2% 13/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.7% 3/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Laryngitis	8.3% 2/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pharyngitis	8.3% 2/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.5% 1/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 1/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 3/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 2/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bronchitis	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 8/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastroenteritis	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 6/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 2/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Hordeolum	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Nasopharyngitis	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	13.6% 3/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.7% 2/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.1% 16/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.7% 3/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.8% 2/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	34.8% 8/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	53.8% 7/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.1% 32/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	26.4% 14/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Viral infection	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Viral rash	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Back pain	8.3% 2/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Joint stiffness	4.2% 1/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.5% 1/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 2/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 1/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 2/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 4/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 1/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 2/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Injection site pain	8.3% 2/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 2/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 2/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Injection site erythema	4.2% 1/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 2/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 2/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 6/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Influenza like illness	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 2/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.7% 2/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.9% 11/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.3% 6/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	4.2% 1/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 2/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.7% 3/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.2% 1/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.8% 2/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 2/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 1/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.5% 4/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.5% 1/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.5% 1/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.1% 5/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.7% 2/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	4.2% 1/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	13.0% 3/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 2/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Food poisoning	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Mouth ulceration	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.5% 1/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	23.1% 3/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.5% 4/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Conjunctival haemorrhage	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Conjunctivitis	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Conjunctivitis allergic	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Eye pain	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 1/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Photophobia	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Laceration	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 1/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood pressure increased	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Anxiety	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Depression	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Endometriosis	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.63% 1/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 2/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.5% 1/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 1/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 1/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 2/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 2/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Urticaria papular	0.00% 0/24 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/13 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/159 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/53 • Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER