Trial Outcomes & Findings for Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children (NCT NCT02153112)

Results Overview

Seroresponse was defined as 4-fold rise or greater at Day 57 in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

840 participants

Primary outcome timeframe

Day 57

Results posted on

2019-04-01

Participant Flow

Participants took part in the study at 12 investigative sites in Finland, Panama, and Colombia from 23 June 2015 to 20 June 2018.

Healthy volunteers (children, toddlers and infants) were enrolled to receive either one, two or three doses of 4 formulation of norovirus GI.1/GII4 bivalent virus like particle (VLP) vaccine.

Participant milestones

Participant milestones
Measure	Cohort 1, Group 1: 1 Dose Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Overall Study STARTED	61	59	61	59	60	60	60	60	180	180
Overall Study COMPLETED	57	57	58	57	57	58	52	58	165	166
Overall Study NOT COMPLETED	4	2	3	2	3	2	8	2	15	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1, Group 1: 1 Dose Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Overall Study Adverse Event	0	0	1	0	0	0	0	0	0	0
Overall Study Lost to Follow-up	1	1	0	0	2	1	1	0	1	1
Overall Study Withdrawal by Subject	3	1	2	2	1	1	7	2	13	12
Overall Study Reason not Specified	0	0	0	0	0	0	0	0	1	1

Baseline Characteristics

Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1, Group 1: 1 Dose n=54 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=54 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=55 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=57 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=52 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=56 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=52 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=56 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=144 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=162 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.	Total n=742 Participants Total of all reporting groups
Age, Continuous	5.9 years n=5 Participants	5.8 years n=7 Participants	2.1 years n=5 Participants	2.1 years n=4 Participants	1.9 years n=21 Participants	2.1 years n=8 Participants	8.3 years n=8 Participants	7.9 years n=24 Participants	3.1 years n=42 Participants	3.0 years n=42 Participants	4.22 years n=42 Participants
Age, Customized EU Registration Age Categories · Infants and Toddlers (28 days-23 months)	0 Participants n=5 Participants	0 Participants n=7 Participants	17 Participants n=5 Participants	19 Participants n=4 Participants	15 Participants n=21 Participants	14 Participants n=8 Participants	52 Participants n=8 Participants	56 Participants n=24 Participants	144 Participants n=42 Participants	162 Participants n=42 Participants	479 Participants n=42 Participants
Age, Customized EU Registration Age Categories · Children (2-11 years)	54 Participants n=5 Participants	54 Participants n=7 Participants	38 Participants n=5 Participants	38 Participants n=4 Participants	37 Participants n=21 Participants	42 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	263 Participants n=42 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	24 Participants n=7 Participants	27 Participants n=5 Participants	25 Participants n=4 Participants	28 Participants n=21 Participants	19 Participants n=8 Participants	24 Participants n=8 Participants	27 Participants n=24 Participants	77 Participants n=42 Participants	72 Participants n=42 Participants	355 Participants n=42 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	32 Participants n=4 Participants	24 Participants n=21 Participants	37 Participants n=8 Participants	28 Participants n=8 Participants	29 Participants n=24 Participants	67 Participants n=42 Participants	90 Participants n=42 Participants	387 Participants n=42 Participants
Race/Ethnicity, Customized Hispanic or Latino	26 Participants n=5 Participants	24 Participants n=7 Participants	26 Participants n=5 Participants	29 Participants n=4 Participants	52 Participants n=21 Participants	56 Participants n=8 Participants	52 Participants n=8 Participants	56 Participants n=24 Participants	144 Participants n=42 Participants	162 Participants n=42 Participants	627 Participants n=42 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	28 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	27 Participants n=4 Participants	0 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	113 Participants n=42 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 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	2 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	18 Participants n=5 Participants	19 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	11 Participants n=21 Participants	10 Participants n=8 Participants	24 Participants n=8 Participants	29 Participants n=24 Participants	69 Participants n=42 Participants	75 Participants n=42 Participants	273 Participants n=42 Participants
Race/Ethnicity, Customized Asian	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	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants	10 Participants n=8 Participants	7 Participants n=8 Participants	5 Participants n=24 Participants	16 Participants n=42 Participants	24 Participants n=42 Participants	73 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islanders	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	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized White	28 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	27 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	121 Participants n=42 Participants
Race/Ethnicity, Customized Multiracial	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 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	2 Participants n=42 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants	20 Participants n=4 Participants	33 Participants n=21 Participants	34 Participants n=8 Participants	17 Participants n=8 Participants	22 Participants n=24 Participants	58 Participants n=42 Participants	60 Participants n=42 Participants	271 Participants n=42 Participants
Height	117.4 cm n=5 Participants	116.5 cm n=7 Participants	89.9 cm n=5 Participants	89.8 cm n=4 Participants	89.7 cm n=21 Participants	89.9 cm n=8 Participants	70.6 cm n=8 Participants	69.3 cm n=24 Participants	60.2 cm n=42 Participants	60.2 cm n=42 Participants	85.35 cm n=42 Participants
Weight	22.41 kg n=5 Participants	22.19 kg n=7 Participants	13.55 kg n=5 Participants	13.39 kg n=4 Participants	13.19 kg n=21 Participants	13.11 kg n=8 Participants	9.02 kg n=8 Participants	8.85 kg n=24 Participants	6.33 kg n=42 Participants	6.35 kg n=42 Participants	12.839 kg n=42 Participants

PRIMARY outcome

Timeframe: Day 57

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Seroresponse was defined as 4-fold rise or greater at Day 57 in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=53 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=52 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=51 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=56 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=47 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=54 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=49 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=55 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 1	77.4 percentage of participants Interval 63.8 to 87.7	63.5 percentage of participants Interval 49.0 to 76.4	74.5 percentage of participants Interval 60.4 to 85.7	85.7 percentage of participants Interval 73.8 to 93.6	53.2 percentage of participants Interval 38.1 to 67.9	70.4 percentage of participants Interval 56.4 to 82.0	71.4 percentage of participants Interval 56.7 to 83.4	92.7 percentage of participants Interval 82.4 to 98.0	—	—

PRIMARY outcome

Timeframe: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Seroresponse was defined as 4-fold rise or greater at Day 140 in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=131 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=146 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 2	57.3 percentage of participants Interval 48.3 to 65.9	84.9 percentage of participants Interval 78.1 to 90.3	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 after either of the vaccination given on Days 1, 29, 56 or 112

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=61 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=59 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=60 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=60 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=180 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=179 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 1 Any solicited local AEs	52.5 percentage of participants	66.1 percentage of participants	34.4 percentage of participants	45.8 percentage of participants	26.7 percentage of participants	30.0 percentage of participants	11.7 percentage of participants	13.3 percentage of participants	22.2 percentage of participants	30.7 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 1 Pain	52.5 percentage of participants	66.1 percentage of participants	34.4 percentage of participants	35.6 percentage of participants	26.7 percentage of participants	25.0 percentage of participants	8.3 percentage of participants	13.3 percentage of participants	22.2 percentage of participants	28.5 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 1 Erythema	0 percentage of participants	1.7 percentage of participants	1.6 percentage of participants	0 percentage of participants	0 percentage of participants	1.7 percentage of participants	3.3 percentage of participants	0 percentage of participants	1.1 percentage of participants	2.8 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 1 Induration	1.6 percentage of participants	1.7 percentage of participants	0 percentage of participants	1.7 percentage of participants	0 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 1 Swelling	0 percentage of participants	5.1 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	1.7 percentage of participants	0 percentage of participants	0 percentage of participants	0.6 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Day 1 after either of the vaccination given on Days 1, 29, 56 or 112

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=60 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=58 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=58 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=59 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=176 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=178 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 2 Any solicited local AEs	41.0 percentage of participants	44.1 percentage of participants	8.2 percentage of participants	25.4 percentage of participants	13.3 percentage of participants	15.0 percentage of participants	10.0 percentage of participants	5.0 percentage of participants	13.3 percentage of participants	14.5 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 2 Pain	41.7 percentage of participants	44.8 percentage of participants	6.6 percentage of participants	23.7 percentage of participants	13.3 percentage of participants	13.3 percentage of participants	6.9 percentage of participants	5.1 percentage of participants	13.6 percentage of participants	14.6 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 2 Erythema	0 percentage of participants	0 percentage of participants	3.3 percentage of participants	5.1 percentage of participants	0 percentage of participants	0 percentage of participants	1.7 percentage of participants	0 percentage of participants	0.6 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 2 Induration	0 percentage of participants	0 percentage of participants	0 percentage of participants	1.7 percentage of participants	0 percentage of participants	1.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 2 Swelling	0 percentage of participants	0 percentage of participants	0 percentage of participants	1.7 percentage of participants	0 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	0 percentage of participants	0.6 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Day 3 after either of the vaccination given on Days 1, 29, 56 or 112

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=60 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=58 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=58 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=59 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=176 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=178 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 3 Any solicited local AEs	13.1 percentage of participants	15.3 percentage of participants	4.9 percentage of participants	20.3 percentage of participants	10.0 percentage of participants	10.0 percentage of participants	5.0 percentage of participants	6.7 percentage of participants	2.2 percentage of participants	5.0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 3 Pain	13.3 percentage of participants	15.5 percentage of participants	4.9 percentage of participants	20.3 percentage of participants	10.0 percentage of participants	8.3 percentage of participants	3.4 percentage of participants	6.8 percentage of participants	2.3 percentage of participants	5.1 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 3 Erythema	0 percentage of participants	0 percentage of participants	1.6 percentage of participants	3.4 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 3 Induration	0 percentage of participants	0 percentage of participants	1.6 percentage of participants	0 percentage of participants	0 percentage of participants	1.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 3 Swelling	0 percentage of participants	0 percentage of participants	1.6 percentage of participants	3.4 percentage of participants	0 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Day 4 after either of the vaccination given on Days 1, 29, 56 or 112

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=60 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=58 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=58 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=59 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=176 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=178 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 4 Erythema	0 percentage of participants	0 percentage of participants	1.6 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 4 Induration	0 percentage of participants	0 percentage of participants	1.6 percentage of participants	1.7 percentage of participants	0 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 4 Swelling	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	1.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 4 Any solicited local AEs	6.6 percentage of participants	6.8 percentage of participants	1.6 percentage of participants	11.9 percentage of participants	6.7 percentage of participants	10.0 percentage of participants	6.7 percentage of participants	6.7 percentage of participants	3.3 percentage of participants	4.5 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 4 Pain	6.7 percentage of participants	6.9 percentage of participants	0 percentage of participants	11.9 percentage of participants	6.7 percentage of participants	6.7 percentage of participants	5.2 percentage of participants	6.8 percentage of participants	3.4 percentage of participants	4.5 percentage of participants

PRIMARY outcome

Timeframe: Day 5 after either of the vaccination given on Days 1, 29, 56 or 112

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=60 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=58 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=58 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=59 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=176 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=178 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 5 Pain	0 percentage of participants	5.2 percentage of participants	0 percentage of participants	5.1 percentage of participants	3.3 percentage of participants	1.7 percentage of participants	3.4 percentage of participants	8.5 percentage of participants	1.7 percentage of participants	2.8 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 5 Erythema	0 percentage of participants	0 percentage of participants	1.6 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 5 Swelling	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 5 Any solicited local AEs	0 percentage of participants	5.1 percentage of participants	1.6 percentage of participants	5.1 percentage of participants	3.3 percentage of participants	1.7 percentage of participants	3.3 percentage of participants	8.3 percentage of participants	1.7 percentage of participants	2.8 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 5 Induration	0 percentage of participants	0 percentage of participants	1.6 percentage of participants	1.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Day 6 after either of the vaccination given on Days 1, 29, 56 or 112

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=60 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=58 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=58 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=59 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=176 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=179 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 6 Pain	3.3 percentage of participants	3.4 percentage of participants	0 percentage of participants	3.4 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	5.1 percentage of participants	0.6 percentage of participants	4.5 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 6 Erythema	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 6 Induration	0 percentage of participants	0 percentage of participants	0 percentage of participants	1.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	1.7 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 6 Swelling	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 6 Any solicited local AEs	3.3 percentage of participants	3.4 percentage of participants	0 percentage of participants	3.4 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	5.0 percentage of participants	1.1 percentage of participants	4.5 percentage of participants

PRIMARY outcome

Timeframe: Day 7 after either of the vaccination given on Days 1, 29, 56 or 112

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=60 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=58 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=58 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=59 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=176 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=178 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 7 Any solicited local AEs	1.6 percentage of participants	3.4 percentage of participants	0 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	3.3 percentage of participants	0.6 percentage of participants	2.2 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 7 Pain	1.7 percentage of participants	3.4 percentage of participants	0 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	3.4 percentage of participants	0.6 percentage of participants	2.2 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 7 Induration	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 7 Erythema	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 7 Swelling	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Days 1 through 7 after each vaccination given on Days 1, 29, 56 or 112

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine).

Systemic AEs are defined as headache, fatigue, myalgia, arthralgia, vomiting (number per day/intensity), and diarrhea (number per day/consistency) for children aged 4 to \<9 years; and irritability/fussiness, drowsiness, loss of appetite, vomiting (number per day/intensity), and diarrhea (number per day/consistency) for children aged 6 weeks to \<4 years on the day of vaccination and daily through Day 7 after each vaccination.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=61 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=59 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=60 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=60 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=180 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=179 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Headache	21.7 percentage of participants	25.9 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Myalgia	26.7 percentage of participants	24.1 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Arthralgia	1.7 percentage of participants	6.9 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Vomiting	8.3 percentage of participants	5.2 percentage of participants	6.6 percentage of participants	6.8 percentage of participants	10.0 percentage of participants	11.7 percentage of participants	27.6 percentage of participants	16.9 percentage of participants	21.6 percentage of participants	23.6 percentage of participants
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Any solicited systemic AEs	50.8 percentage of participants	61.0 percentage of participants	44.3 percentage of participants	54.2 percentage of participants	41.7 percentage of participants	43.3 percentage of participants	56.7 percentage of participants	50.0 percentage of participants	60.0 percentage of participants	59.2 percentage of participants
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Fatigue	23.3 percentage of participants	29.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Diarrhea	6.9 percentage of participants	10.7 percentage of participants	13.1 percentage of participants	23.7 percentage of participants	18.3 percentage of participants	18.3 percentage of participants	31.0 percentage of participants	25.4 percentage of participants	31.8 percentage of participants	30.9 percentage of participants
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Irritability/Fussiness	0 percentage of participants	0 percentage of participants	23.0 percentage of participants	30.5 percentage of participants	23.3 percentage of participants	18.3 percentage of participants	27.6 percentage of participants	23.7 percentage of participants	40.3 percentage of participants	41.6 percentage of participants
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Drowsiness	0 percentage of participants	0 percentage of participants	16.4 percentage of participants	22.0 percentage of participants	23.3 percentage of participants	21.7 percentage of participants	22.4 percentage of participants	20.3 percentage of participants	33.5 percentage of participants	33.1 percentage of participants
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Loss of Appetite	0 percentage of participants	0 percentage of participants	21.3 percentage of participants	33.9 percentage of participants	16.7 percentage of participants	18.3 percentage of participants	25.9 percentage of participants	23.7 percentage of participants	22.7 percentage of participants	19.7 percentage of participants

PRIMARY outcome

Timeframe: Post-vaccination approximately 30 minutes and 6 hours later, then daily through Day 7 after each vaccination given on Days 1, 29, 56 or 112

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine).

Body temperature measurement was performed using the thermometer provided by the site through Day 7 after each vaccination. The highest body temperature observed each day was recorded on the Diary Card. Body temperature is categorized as 1) Any (temperature 38°C or higher), 2) 38°C - \<38.5°C, 3) 38.5°C - \<39°C, 4) 39°C - \<39.5°C, 5) 39.5°C - \<40°C, 6) 40°C or higher. Number of participants with the particular body temperature is reported within the pre-defined categories.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=61 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=59 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=60 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=60 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=180 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=179 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Body Temperature Through Day 7 Following Either Vaccination Any (temperature 38°C or higher)	2 participants	6 participants	7 participants	5 participants	6 participants	8 participants	8 participants	11 participants	26 participants	23 participants
Body Temperature Through Day 7 Following Either Vaccination 38°C - <38.5°C	0 participants	2 participants	2 participants	3 participants	4 participants	4 participants	5 participants	4 participants	13 participants	11 participants
Body Temperature Through Day 7 Following Either Vaccination 38.5°C - <39°C	1 participants	2 participants	3 participants	2 participants	1 participants	3 participants	3 participants	2 participants	12 participants	7 participants
Body Temperature Through Day 7 Following Either Vaccination 40°C or higher	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Body Temperature Through Day 7 Following Either Vaccination 39°C - <39.5°C	1 participants	2 participants	1 participants	0 participants	1 participants	1 participants	0 participants	3 participants	0 participants	3 participants
Body Temperature Through Day 7 Following Either Vaccination 39.5°C - <40°C	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	2 participants	1 participants	2 participants

PRIMARY outcome

Timeframe: Unsolicited AEs were collected within 28 days of all vaccinations (Day 1 to 57 for Cohort 1 and Day 1 to 140 for Cohort 2)

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine).

Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=61 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=59 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=60 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=60 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=180 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=179 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With at Least One Unsolicited AE Following Either Vaccination Dose	55.7 percentage of participants	55.9 percentage of participants	67.2 percentage of participants	69.5 percentage of participants	55.0 percentage of participants	46.7 percentage of participants	73.3 percentage of participants	70.0 percentage of participants	77.2 percentage of participants	76.0 percentage of participants

PRIMARY outcome

Timeframe: Cohort 1: Day 1 up to Day 210; Cohort 2: Day 1 up to Day 293

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine).

A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=61 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=59 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=60 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=60 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=180 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=179 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With Serious Adverse Events (SAEs)	1.6 percentage of participants	3.4 percentage of participants	1.6 percentage of participants	3.4 percentage of participants	10.0 percentage of participants	1.7 percentage of participants	10.0 percentage of participants	8.3 percentage of participants	9.4 percentage of participants	13.4 percentage of participants

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Here, overall number of participants analyzed is the number of participants with data available at the given time point.

Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=53 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=52 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=51 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=56 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=47 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=54 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=49 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=55 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=138 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=150 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With a Seroresponse for GI.1 Virus-Like Particle (VLP) (Pan-Ig ELISA)	88.7 percentage of participants Interval 77.0 to 95.7	82.7 percentage of participants Interval 69.7 to 91.8	92.2 percentage of participants Interval 81.1 to 97.8	92.9 percentage of participants Interval 82.7 to 98.0	78.7 percentage of participants Interval 64.3 to 89.3	94.4 percentage of participants Interval 84.6 to 98.8	95.9 percentage of participants Interval 86.0 to 99.5	100.0 percentage of participants Interval 93.5 to 100.0	94.9 percentage of participants Interval 89.8 to 97.9	98.0 percentage of participants Interval 94.3 to 99.6

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-Like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=53 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=52 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=51 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=56 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=47 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=54 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=49 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=55 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=134 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=150 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With a Seroresponse for GII.4 Virus-Like Particle (VLP) (Pan-Ig ELISA)	81.1 percentage of participants Interval 68.0 to 90.6	69.2 percentage of participants Interval 54.9 to 81.3	76.5 percentage of participants Interval 62.5 to 87.2	87.5 percentage of participants Interval 75.9 to 94.8	63.8 percentage of participants Interval 48.5 to 77.3	72.2 percentage of participants Interval 58.4 to 83.5	75.5 percentage of participants Interval 61.1 to 86.7	92.7 percentage of participants Interval 82.4 to 98.0	58.2 percentage of participants Interval 49.4 to 66.7	86.0 percentage of participants Interval 79.4 to 91.1

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=53 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=52 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=51 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=56 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=47 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=54 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=49 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=55 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=144 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=162 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)	6039.1 titer Interval 4786.3 to 7619.9	12907.6 titer Interval 10875.5 to 15319.4	2856.2 titer Interval 2232.0 to 3654.9	7350.8 titer Interval 6208.6 to 8703.2	3892.1 titer Interval 2852.7 to 5310.3	12623.8 titer Interval 10074.0 to 15818.9	1240.1 titer Interval 948.3 to 1621.7	7139.1 titer Interval 5863.5 to 8692.2	4121.1 titer Interval 3688.4 to 4604.6	11806.3 titer Interval 10537.6 to 13227.8

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=53 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=52 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=51 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=56 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=47 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=54 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=49 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=55 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=143 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=162 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)	11057.9 titer Interval 8257.3 to 14808.3	10228.3 titer Interval 8171.2 to 12803.3	3293.0 titer Interval 2220.5 to 4883.3	7955.2 titer Interval 6065.9 to 10433.0	5950.6 titer Interval 3927.2 to 9016.7	10896.5 titer Interval 8452.0 to 14048.0	620.2 titer Interval 383.7 to 1002.7	3252.1 titer Interval 2403.3 to 4400.7	1316.2 titer Interval 1103.9 to 1569.4	3829.8 titer Interval 3311.7 to 4428.9

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=53 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=52 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=51 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=56 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=47 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=54 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=49 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=55 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=138 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=150 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)	19.22 ratio Interval 12.98 to 28.44	43.55 ratio Interval 25.21 to 75.25	44.11 ratio Interval 28.48 to 68.32	89.95 ratio Interval 56.51 to 143.18	13.01 ratio Interval 7.92 to 21.37	43.99 ratio Interval 27.71 to 69.83	47.45 ratio Interval 30.59 to 73.6	276.41 ratio Interval 206.44 to 370.09	34.11 ratio Interval 26.54 to 43.84	122.80 ratio Interval 93.93 to 160.54

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=53 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=52 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=51 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=56 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=47 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=54 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=49 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=55 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=134 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=150 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)	7.46 ratio Interval 5.63 to 9.87	10.00 ratio Interval 6.74 to 14.85	10.87 ratio Interval 7.48 to 15.77	19.20 ratio Interval 12.66 to 29.11	5.62 ratio Interval 3.83 to 8.22	11.93 ratio Interval 7.46 to 19.07	9.54 ratio Interval 5.8 to 15.71	55.73 ratio Interval 36.5 to 85.09	7.85 ratio Interval 5.86 to 10.5	23.55 ratio Interval 17.85 to 31.08

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=48 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=47 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=44 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=49 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=43 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=47 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=30 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=41 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=129 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=144 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP (HBGA)	75.0 percentage of participants Interval 60.4 to 86.4	91.5 percentage of participants Interval 79.6 to 97.6	50.0 percentage of participants Interval 34.6 to 65.4	95.9 percentage of participants Interval 86.0 to 99.5	51.2 percentage of participants Interval 35.5 to 66.7	89.4 percentage of participants Interval 76.9 to 96.5	36.7 percentage of participants Interval 19.9 to 56.1	85.4 percentage of participants Interval 70.8 to 94.4	48.1 percentage of participants Interval 39.2 to 57.0	67.4 percentage of participants Interval 59.1 to 74.9

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by HBGA binding assay.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=52 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=50 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=49 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=53 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=43 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=50 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=40 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=50 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=137 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=157 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)	94.2 percentage of participants Interval 84.1 to 98.8	98.0 percentage of participants Interval 89.4 to 99.9	81.6 percentage of participants Interval 68.0 to 91.2	100.0 percentage of participants Interval 93.3 to 100.0	74.4 percentage of participants Interval 58.8 to 86.5	98.0 percentage of participants Interval 89.4 to 99.9	50.0 percentage of participants Interval 33.8 to 66.2	96.0 percentage of participants Interval 86.3 to 99.5	92.0 percentage of participants Interval 86.1 to 95.9	94.9 percentage of participants Interval 90.2 to 97.8

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=49 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=48 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=45 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=49 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=47 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=51 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=38 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=46 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=134 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=147 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)	81.6 percentage of participants Interval 68.0 to 91.2	93.8 percentage of participants Interval 82.8 to 98.7	64.4 percentage of participants Interval 48.8 to 78.1	95.9 percentage of participants Interval 86.0 to 99.5	68.1 percentage of participants Interval 52.9 to 80.9	90.2 percentage of participants Interval 78.6 to 96.7	47.4 percentage of participants Interval 31.0 to 64.2	87.0 percentage of participants Interval 73.7 to 95.1	48.5 percentage of participants Interval 39.8 to 57.3	70.7 percentage of participants Interval 62.7 to 78.0

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=52 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=51 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=49 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=53 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=45 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=53 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=42 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=52 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=142 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=162 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)	166.4 titer Interval 136.0 to 203.6	491.4 titer Interval 397.1 to 608.1	135.2 titer Interval 106.5 to 171.7	346.0 titer Interval 297.5 to 402.3	145.0 titer Interval 108.6 to 193.8	531.1 titer Interval 424.0 to 665.2	63.1 titer Interval 45.3 to 87.9	350.1 titer Interval 273.7 to 447.9	202.2 titer Interval 180.7 to 226.2	561.7 titer Interval 499.2 to 632.1

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=50 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=49 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=46 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=51 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=47 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=54 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=43 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=51 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=136 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=150 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Blocking Titers 50 (BT50) of Anti-Norovirus GII.4 VLP Antibody Titers (HBGA)	982.1 titer Interval 652.4 to 1478.4	933.6 titer Interval 678.3 to 1284.9	197.1 titer Interval 119.0 to 326.5	514.8 titer Interval 372.1 to 712.3	444.6 titer Interval 261.9 to 754.8	721.8 titer Interval 510.2 to 1021.1	68.5 titer Interval 44.1 to 106.4	282.6 titer Interval 194.8 to 410.0	102.4 titer Interval 83.1 to 126.1	243.9 titer Interval 203.3 to 292.8

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=52 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=50 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=49 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=53 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=43 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=50 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=40 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=50 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=137 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=157 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)	8.93 ratio Interval 7.58 to 10.53	23.07 ratio Interval 18.56 to 28.68	7.22 ratio Interval 5.47 to 9.52	22.15 ratio Interval 19.06 to 25.73	6.10 ratio Interval 4.41 to 8.42	24.21 ratio Interval 19.36 to 30.29	3.68 ratio Interval 2.64 to 5.13	20.01 ratio Interval 15.54 to 25.76	11.48 ratio Interval 10.09 to 13.06	32.03 ratio Interval 27.38 to 37.47

SECONDARY outcome

Timeframe: Cohort 1: Day 57; Cohort 2: Day 140

Population: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=49 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=48 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=45 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=49 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=47 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=51 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=38 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=46 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=134 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=147 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)	9.31 ratio Interval 6.93 to 12.52	12.73 ratio Interval 9.6 to 16.9	5.35 ratio Interval 3.94 to 7.28	15.95 ratio Interval 12.31 to 20.66	8.34 ratio Interval 5.01 to 13.87	15.36 ratio Interval 11.26 to 20.96	3.91 ratio Interval 2.6 to 5.88	17.00 ratio Interval 11.66 to 24.8	3.73 ratio Interval 2.84 to 4.9	8.13 ratio Interval 6.39 to 10.35

SECONDARY outcome

Timeframe: Cohort 1: Day 1 up to Day 210; Cohort 2: Day 1 up to Day 293

Population: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine).

Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the participant's health or the participant is unwilling to continue because of the AE.

Outcome measures

Outcome measures
Measure	Cohort 1, Group 1: 1 Dose n=61 Participants Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=59 Participants Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 Participants Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 Participants Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=60 Participants Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=60 Participants Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=180 Participants Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=179 Participants Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study	0 percentage of participants	0 percentage of participants	1.6 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

Adverse Events

Cohort 1, Group 1: 1 Dose

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Cohort 1, Group 1: 2 Doses

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Cohort 1, Group 2: 1 Dose

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Cohort 1, Group 2: 2 Doses

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Cohort 1, Group 2a: 1 Dose

Serious events: 6 serious events

Other events: 21 other events

Deaths: 0 deaths

Cohort 1, Group 2a: 2 Doses

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Cohort 1, Group 3: 1 Dose

Serious events: 6 serious events

Other events: 36 other events

Deaths: 0 deaths

Cohort 1, Group 3: 2 Doses

Serious events: 5 serious events

Other events: 35 other events

Deaths: 0 deaths

Cohort 2, Group 4: 2 Doses

Serious events: 17 serious events

Other events: 119 other events

Deaths: 0 deaths

Cohort 2, Group 4: 3 Doses

Serious events: 24 serious events

Other events: 122 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1, Group 1: 1 Dose n=61 participants at risk Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=59 participants at risk Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 participants at risk Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 participants at risk Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 participants at risk Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 participants at risk Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=60 participants at risk Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=60 participants at risk Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=180 participants at risk Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=179 participants at risk Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Infections and infestations Pneumonia	1.6% 1/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 2/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 2/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 6/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 9/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.4% 2/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.6% 1/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 2/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Enteritis	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Furuncle	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Atypical Pneumonia	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Otitis Media Acute	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Upper Respiratory Tract Infection	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Testicular Torsion	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Asthmatic Crisis	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 2/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Bronchiolitis	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 2/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 2/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 4/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Tracheitis	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Incarcerated Inguinal Hernia	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 4/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Croup Infectious	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Bacterial	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Muscle Abscess	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Subcutaneous Abscess	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 2/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Burns Third Degree	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Intussusception	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Pneumonia Respiratory Syncytial Viral	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 2/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Pneumonia Bacterial	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Encephalitis	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Periorbital Cellulitis	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.56% 1/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 viral	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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	Cohort 1, Group 1: 1 Dose n=61 participants at risk Children 4 to \<9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.	Cohort 1, Group 1: 2 Doses n=59 participants at risk Children 4 to \<9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.	Cohort 1, Group 2: 1 Dose n=61 participants at risk Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2: 2 Doses n=59 participants at risk Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 2a: 1 Dose n=60 participants at risk Children 1 to \<4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 2a: 2 Doses n=60 participants at risk Children 1 to \<4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 1, Group 3: 1 Dose n=60 participants at risk Toddlers 6 months to \<1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.	Cohort 1, Group 3: 2 Doses n=60 participants at risk Toddlers 6 months to \<1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.	Cohort 2, Group 4: 2 Doses n=180 participants at risk Infants 6 weeks to \<6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.	Cohort 2, Group 4: 3 Doses n=179 participants at risk Infants 6 weeks to \<6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
Gastrointestinal disorders Abdominal Pain Upper	4.9% 3/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 8/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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	24.6% 15/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.9% 7/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 5/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 8/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	23.3% 14/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 10/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	38.3% 23/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	40.0% 24/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	47.8% 86/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	51.4% 92/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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	1.6% 1/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.8% 4/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	13.1% 8/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.9% 7/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.7% 4/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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	3.3% 2/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.5% 5/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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	6.6% 4/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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	3.3% 2/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.5% 5/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.6% 4/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.5% 5/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.1% 3/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.9% 3/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.1% 3/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 5/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 2/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 10/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.4% 15/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.8% 4/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.6% 4/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.1% 3/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 6/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 10/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Rhinitis	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 5/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.8% 4/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Conjunctivitis	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.6% 4/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.4% 2/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.4% 8/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.9% 7/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Otitis Media	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.6% 4/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.5% 5/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 5/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 5/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 2/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 3/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 15/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.1% 11/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 2/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 5/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.1% 11/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.1% 11/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 3/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Acarodermatitis	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.7% 4/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 1/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 2/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.8% 5/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Pyoderma	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 3/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Pharyngotonsillitis	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 2/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 3/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 9/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.7% 3/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Bronchiolitis	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 9/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.9% 7/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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 Diaper	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/61 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/59 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/60 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.1% 11/180 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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% 18/179 • Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2) At each visit the investigator had to document any occurrence of adverse events and 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